Methods and apparatus for locating a surface of a body lumen

ABSTRACT

An embodiment of an apparatus for locating a surface of a body lumen is disclosed. The apparatus includes a locator assembly that has a distal end region configured to extend into an opening of the body lumen and to selectably engage at least a portion of the body lumen adjacent to the opening. The distal end region includes at least one surface engaging element that is configured to engage the surface of the body lumen. The apparatus includes a measuring device that is in electrical communication with the surface engaging element. The measuring device is configured to determine changes in measurable characteristics of the surface engaging element. Methods and apparatus for locating a surface of a body lumen are also disclosed.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.12/393,877, filed Feb. 26, 2009, which is incorporated by reference inits entirety.

This application also incorporates U.S. Pat. Nos. 6,197,042 and6,623,510, and U.S. patent application Ser. Nos. 09/546,998, 09/610,238,09/680,837, 09/732,835, 10/081,723, and 10/081,726 by reference each intheir entirety.

BACKGROUND OF THE INVENTION

1. The Field of the Invention

The present invention relates generally to medical devices, and moreparticular to methods and apparatuses for locating a surface of a bodylumen.

2. The Related Technology

Catheterization and interventional procedures, such as angioplasty orstenting, generally are performed by inserting a hollow needle through apatient's skin and tissue into the vascular system. A guide wire may beadvanced through the needle and into the patients blood vessel accessedby the needle. The needle is then removed, enabling an introducer sheathto be advanced over the guide wire into the vessel, e.g., in conjunctionwith or subsequent to a dilator.

A catheter or other device may then be advanced through a lumen of theintroducer sheath and over the guide wire into a position for performinga medical procedure. Thus, the introducer sheath may facilitateintroducing various devices into the vessel, while minimizing trauma tothe vessel wall and/or minimizing blood loss during a procedure.

Upon completing the procedure, the devices and introducer sheath wouldbe removed, leaving a puncture site in the vessel wall. Traditionally,external pressure would be applied to the puncture site until clottingand wound sealing occur; however, the patient must remain bedridden fora substantial period of time after clotting to ensure closure of thewound. This procedure, however, may be time consuming and expensive,requiring as much as an hour of a physician's or nurse's time. It isalso uncomfortable for the patient, and requires that the patient remainimmobilized in the operating room, catheter lab, or holding area. Inaddition, a risk of hematoma exists from bleeding before hemostasisoccurs.

Various apparatus have been suggested for percutaneously sealing avascular puncture by occluding the puncture site. For example, U.S. Pat.Nos. 5,192,302 and 5,222,974, issued to Kensey et al., describe the useof a biodegradable plug that may be delivered through an introducersheath into a puncture site. Another technique has been suggested thatinvolves percutaneously suturing the puncture site, such as thatdisclosed in U.S. Pat. No. 5,304,184, issued to Hathaway et al.

To facilitate positioning devices that are percutaneously inserted intoa blood vessel, “bleed back” indicators have been suggested. Forexample, U.S. Pat. No. 5,676,689, issued to Kensey et al., discloses ableed back lumen intended to facilitate positioning of a biodegradableplug within a puncture site.

Alternatively, U.S. Pat. No. 5,674,231, issued to Green et al.,discloses a deployable loop that may be advanced through a sheath into avessel. The loop is intended to resiliently expand to engage the innerwall of the vessel, thereby facilitating holding the sheath in a desiredlocation with respect to the vessel.

Accordingly, apparatus and methods for locating a surface of a bodylumen would be useful.

BRIEF SUMMARY OF THE INVENTION

An embodiment of an apparatus for locating a surface of a body lumen isdisclosed. The apparatus includes a locator assembly that has a distalend region configured to extend into an opening of the body lumen and toselectably engage at least a portion of the body lumen adjacent to theopening. The distal end region includes at least one surface engagingelement that is configured to engage the surface of the body lumen. Theapparatus includes a measuring device that is in electricalcommunication with the surface engaging element. The measuring device isconfigured to determine changes in measurable characteristics of thesurface engaging element.

An embodiment of method for locating a surface of a body lumen isdisclosed. The method includes inserting a locator assembly through anopening of the body lumen. The locator assembly includes a distal endregion having a surface engaging element configured to selectivelyengage the surface of the body lumen. The locator assembly is positionedin close proximity to the opening of the body lumen. A measurablecharacteristic of the surface engaging element is measured within thebody lumen. It is determined whether the measurable characteristic ofthe surface engaging element indicates that the surface engaging elementhas engaged the surface of the body lumen.

An embodiment of a surface engaging element is disclosed. The surfaceengaging element includes a proximal end portion that has at least oneretaining portion. The surface engaging element includes a distal endportion that has at least one retaining portion. The surface engagingelement includes at least one engaging member that extends toward theproximal end portion and extends toward the distal end portion. The atleast one engaging member is configured to engage a surface of a bodylumen.

Additional features and advantages of the invention will be set forth inthe description which follows, and in part will be obvious from thedescription, or may be learned by the practice of the invention. Thefeatures and advantages of the invention may be realized and obtained bymeans of the instruments and combinations particularly pointed out inthe appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

In order that the manner in which the above-recited and other advantagesand features of the invention are obtained, a more particulardescription of the invention briefly described above will be rendered byreference to specific embodiments thereof which are illustrated in theappended drawings. Understanding that these drawings depict only typicalembodiments of the invention and are not therefore to be consideredlimiting of its scope, the invention will be described and explainedwith additional specificity and detail through the use of theaccompanying drawings in which:

FIG. 1 provides a general illustration of an apparatus for closingopenings formed in blood vessel walls in accordance with the presentinvention.

FIG. 2A illustrates one embodiment of a locator assembly for theapparatus of FIG. 1.

FIG. 2B illustrates one embodiment of a distal end region of the locatorassembly of FIG. 2A when the distal end region is in an unexpandedstate.

FIG. 2C illustrates the distal end region of the locator assembly ofFIG. 2B when the distal end region is in an expanded state.

FIGS. 2B′ and 2C′ illustrate an alternative embodiment of a locatorassembly for locating a surface of a body lumen, in accordance with thepresent invention.

FIGS. 2B″ and 2C″ illustrate a further embodiment of a locator assemblyfor locating a surface of a body lumen, in accordance with the presentinvention.

FIGS. 2B′″ and 2C′″ illustrate a still further embodiment of a locatorassembly for locating a surface of a body lumen, in accordance with thepresent invention.

FIG. 2D illustrates one embodiment of a proximal end region of thelocator assembly of FIG. 2A.

FIG. 3A illustrates one embodiment of a carrier assembly for theapparatus of FIG. 1.

FIG. 3B illustrates one embodiment of a carrier member for the carrierassembly of FIG. 3A.

FIG. 3C illustrates one embodiment of a pusher member for the carrierassembly of FIG. 3A.

FIG. 3D illustrates one embodiment of a cover member for the carrierassembly of FIG. 3A.

FIG. 3E illustrates one embodiment of a support member for the carrierassembly of FIG. 3A.

FIG. 4A illustrates a cross-sectional side view of one embodiment of atriggering system for the carrier assembly of FIG. 3A.

FIG. 4B illustrates a first detailed cross-sectional side view of thetriggering system of FIG. 4A.

FIG. 4C illustrates a detailed view of the triggering system of FIG. 4B.

FIG. 4D illustrates a second detailed cross-sectional side view of thetriggering system of FIG. 4A.

FIG. 5A illustrates the carrier control system of FIGS. 4A-D as thecarrier assembly of FIG. 3A moves distally from an initial predeterminedposition.

FIG. 5B illustrates the carrier control system of FIGS. 4A-D as thecarrier assembly of FIG. 3A reaches a first predetermined position.

FIG. 5C illustrates the carrier control system of FIGS. 4A-D as thecarrier assembly of FIG. 3A reaches a second predetermined position.

FIG. 6A illustrates a top view of one embodiment of a closure element ina natural, planar configuration and with a natural cross-section for usewith the apparatus of FIG. 1.

FIG. 6B illustrates a side view of the closure element of FIG. 6A.

FIG. 6C illustrates a top view of the closure element of FIGS. 6A-Bafter a natural cross-section of the closure element has been reduced.

FIG. 6D illustrates a side view of the reduced closure element of FIG.6C.

FIG. 6E illustrates a side view of the reduced closure element of FIGS.6C-D as the reduced closure element transitions from the natural, planarconfiguration to a tubular configuration.

FIG. 6F illustrates a top view of the closure element of FIGS. 6C-D uponcompleting the transition from the natural, planar configuration to asubstantially tubular configuration.

FIG. 6G illustrates a side view of the closure element of FIG. 6F.

FIG. 7A illustrates the closure element of FIGS. 6A-G prior to beingdisposed upon the carrier member of FIG. 3B.

FIG. 7B illustrates the closure element of FIGS. 6A-G upon beingdisposed upon the carrier member of FIG. 3B.

FIG. 7C illustrates the closure element of FIGS. 6A-G as the covermember of FIG. 3D receives the carrier member of FIG. 3B.

FIG. 7D illustrates the closure element of FIGS. 6A-G being retainedsubstantially within the carrier assembly of FIG. 3A when the carriermember of FIG. 3B is disposed substantially within the cover member ofFIG. 3D.

FIG. 8A illustrates a sheath that is positioned through tissue and intoan opening formed in a wall of a blood vessel.

FIG. 8B illustrates the apparatus of FIG. 1 as prepared to be receivedby the sheath of FIG. 8A.

FIG. 8C illustrates a locator assembly of the apparatus of FIG. 8B beingadvanced distally into the blood vessel.

FIG. 8D illustrates a distal end region of the locator assembly of FIG.8C extending into the blood vessel and being transitioned into anexpanded state.

FIG. 8E illustrates the distal end region of FIG. 8D being retractedproximally to engage an inner surface of the blood vessel wall.

FIG. 8F illustrates a carrier assembly of the apparatus of FIG. 8B beingadvanced distally into the sheath of FIG. 8A once the distal end regionof FIG. 8D has engaged the inner surface of the blood vessel wall.

FIG. 8G illustrates relative positions of a tube set of the carrierassembly of FIG. 8F upon reaching a first predetermined position.

FIG. 8H illustrates the relative positions of the tube set of FIG. 8Gupon reaching a second predetermined position.

FIG. 8I illustrates a position of a pusher member of the tube set ofFIG. 8H moving distally from the second predetermined position andbeginning to distally deploy a closure element.

FIG. 8J illustrates the closure element of FIG. 8I upon being deployedand engaging tissue adjacent to the opening in the blood vessel wall.

FIG. 8K illustrates the closure element of FIG. 8J transitioning fromthe substantially tubular configuration to the natural, planarconfiguration while engaging the engaged tissue.

FIG. 8L illustrates the closure element of FIG. 8K drawing the engagedtissue substantially closed and/or sealed

FIG. 9 illustrates one embodiment of an introducer sheath for theapparatus of FIG. 1.

FIG. 10A illustrates an assembly view of the components included in analternative embodiment of the apparatus for closing openings formed inblood vessel walls.

FIG. 10B illustrates an assembly view of the components shown in FIG.10A, showing the reverse view of that shown in FIG. 10A.

FIG. 11A illustrates the assembled carrier assembly and triggeringassembly of the alternative embodiment of the apparatus shown in FIG.10A.

FIG. 11B illustrates a close-up view of the proximal end of theapparatus shown in FIG. 11A.

FIG. 12 illustrates the apparatus of FIG. 11A after advancement of thelocator assembly block.

FIG. 13A illustrates the apparatus of FIG. 12 after distal advancementof the triggering system and carrier assembly. FIG. 13B illustrates aclose-up view of the distal end of the housing and internal componentsof the apparatus shown in FIG. 13A.

FIG. 14A illustrates the apparatus of FIG. 13 after further distaladvancement of the triggering system and carrier assembly.

FIG. 14B illustrates a close-up view of the distal end of the housingand internal components of the apparatus shown in FIG. 14A.

FIG. 15 illustrates a reverse view of the apparatus of FIGS. 11-14,showing the locator release system.

FIG. 16 illustrates a side view of another alternative embodiment of anapparatus for closing openings formed in blood vessel walls.

FIG. 16A illustrates a close-up view of the distal end of the deviceshown in FIG. 16.

FIG. 17 illustrates a perspective view of the proximal end of the deviceshown in FIG. 16.

FIG. 17A illustrates a close-up view of the proximal end of the deviceshown in FIG. 17.

FIG. 18 illustrates a cross-sectional view of the device shown in FIG.16.

FIG. 18A illustrates a close-up cross-sectional view of a portion of thedevice shown in FIG. 18.

FIG. 18B illustrates a close-up cross-sectional view of a portion of thedevice shown in FIG. 18.

FIG. 19 illustrates a close-up cross-sectional view of the proximal endof the device shown in FIG. 16.

FIG. 20A is a cross-sectional side view illustrating an opening formedin a vessel, wherein a guidewire is shown disposed within the opening.

FIGS. 20B-20F are partial cross-sectional views illustrating thealternative embodiment of the closure device in accordance with thepresent invention wherein the device is illustrated being disposed overa guidewire.

FIG. 20G is a partial cross-sectional view illustrating the placement ofa closure element in accordance with the device illustrated in FIGS.20B-20F.

It should be noted that the figures are not drawn to scale and thatelements of similar structures or functions are generally represented bylike reference numerals for illustrative purposes throughout thefigures. It also should be noted that the figures are only intended tofacilitate the description of embodiments of the present invention.

DETAILED DESCRIPTION

The embodiments described herein extend to methods, systems, andapparatus for managing access through tissue. Some of the apparatuses ofthe present invention are configured to deliver a device for managingaccess through tissue into an opening formed in and/or adjacent totissue.

Medical devices may be used in a variety of spaces. It may be desirableto generally reduce the size of medical devices. For example, stents maybe inserted into smaller and smaller vasculature, thus making itgenerally desirable to reduce the pre-deployment size of a stent. Inanother example, a closure device may be used to close tissue in, forexample, a body lumen. In order to reach the desired body lumen,typically a delivery device may be used to reach an access point in thebody lumen. To minimize the effects of a procedure on a patient, thereduction in size of the access point may be desirable.

When engaging tissue and/or closing openings in tissue, it may bedesirable to use a locator assembly to selectably contact a portion ofthe tissue. In some cases, the locator assembly may not contact aportion of the desired tissue. For example, the locator assembly may bepositioned within a body lumen but away from an inside surface of thebody lumen. In these instances, engagement of a portion of the desiredtissue may be less likely and/or favorable. It may be desirable toverify contact with a portion of the desired tissue during a medicalprocedure.

In one embodiment, a locator assembly may include engagement membersconfigured to engage a portion of the desired tissue. The locatorassembly may include a device to take measurements of a desiredmeasurable characteristic. The measurable characteristic may include,for example, impedance. Measurements may be taken when a portion of thelocator assembly is within a body lumen and when the locator assembly isbelieved to be in contact with tissue. Comparing the measurements takenwhen within the body lumen and when the locator assembly is believed tobe in contact with tissue may indicate that the locator assembly hascontacted a portion of the desired tissue. For example, an impedancemeasurement taken when within the body lumen may be higher than animpedance measurement taken when the locator assembly is in contact withtissue.

In a further embodiment, a surface engaging element can be provided. Thesurface engaging element may include a flexible body that may actuatebetween an expanded and relaxed configuration.

In some embodiments, an engagement portion of the surface engagingelement may include substantially uniform dimensions. In otherembodiments, the engagement portion of the surface engaging element mayinclude at least one non-uniform dimension. For example, the engagementportion may have a dimension that is larger than a support portion ofthe surface engaging element.

In further embodiments, the surface engaging element may be assembledusing a retaining portion. For example, an engagement portion may beconnected to a proximal, distal, and/or other portion of the surfaceengaging element by a retaining portion, such as a detent.

These results, whether individually or collectively, can be achieved,according to one embodiment of the present invention, by employingmethods, systems, and/or apparatus as shown in the figures and describedin detail below.

Since current apparatuses for sealing openings formed in blood vesselwalls can snag tissue adjacent to the openings during positioning andmay not provide an adequate seal, an apparatus that is configured toprevent inadvertent tissue contact during positioning and to engage asubstantial of amount of tissue adjacent to the opening can prove muchmore desirable and provide a basis for a wide range of medicalapplications, such as diagnostic and/or therapeutic procedures involvingblood vessels or other body lumens of any size. This result can beachieved, according to one embodiment of the present invention, byemploying an apparatus 100 as shown in FIG. 1.

As will be discussed in more detail below, the apparatus 100 can delivera closure element 500 (shown in FIGS. 6A-B) through tissue 630 (shown inFIG. 8A) and into an opening 610 (shown in FIG. 8A) formed in and/oradjacent to a wall 620 (shown in FIG. 8A) of a blood vessel 600 (shownin FIG. 8A) or other body lumen. The closure element (or clip) 500preferably has a generally annular-shape body 510 (shown in FIGS. 6A-B)defining a channel 540 and one or more barbs and/or tines 520 (shown inFIGS. 6A-B) for receiving and engaging the blood vessel wall 620 and/orthe tissue 630 around the opening 610. Although the closure element 500has a natural shape and size, the closure element 500 can be deformedinto other shapes and sizes, as desired, and is configured to return tothe natural shape and size when released. For example, the closureelement 500 can have a natural, planar configuration with opposing tines520 and a natural cross-section 530 as shown in FIGS. 6A-B. The naturalcross-section 530 of the closure element 500 can be reduced to form areduced closure element 500′ that has a natural, planar configurationwith opposing tines 520 and a reduced cross-section 530′ as shown inFIGS. 6C-D. By rotating the opposing tines 520 axially as shown in FIG.6E, the reduced closure element 500′ can be further deformed to form asubstantially tubular closure element 500″ (shown in FIG. 6F) having thereduced cross-section 530′ as well as being in a substantially tubularconfiguration with the tines 520 in an axial configuration.

Being configured to draw the blood vessel wall 620 and/or the tissue 630adjacent to the opening 610 substantially closed and/or to enhancehemostasis within the opening 610, the closure element 500 can be formedfrom any suitable material, including any biodegradable material, anyshape memory alloy, such as alloys of nickel-titanium, or anycombination thereof. Additionally, it is contemplated that the closureelement may be coated with a beneficial agent or be constructed as acomposite, wherein one component of the composite would be a beneficialagent. As desired, the closure element 500 may further includeradiopaque markers (not shown) or may be wholly or partially formed froma radiopaque material to facilitate observation of the closure element500 using fluoroscopy or other imaging systems. Exemplary embodiments ofa closure element are disclosed in U.S. Pat. Nos. 6,197,042, and6,623,510, and in co-pending application Ser. Nos. 09/546,998,09/610,238, and 10/081,726. The disclosures of these references and anyothers cited therein are expressly incorporated herein by reference.

The apparatus 100 is configured to receive and retain the closureelement 500 such that the closure element 500 is disposed substantiallywithin the apparatus 100. Thereby, if the apparatus 100 is introducedvia an introducer sheath 640 (shown in FIG. 8A), for example, theclosure element 500 can be disposed within, and delivered by way of, alumen 644 (shown in FIG. 8A) of the introducer sheath 640. The apparatus100 also is configured to engage the blood vessel wall 620 adjacent tothe opening 610. Being disposed substantially within the apparatus 100,the closure element 500 can deeply penetrate, without inadvertentlycontacting, tissue 630 adjacent to the opening 610 such that theapparatus 100 can position the closure element 500 substantiallyadjacent to an outer surface 620 a (shown in FIG. 8A) of the bloodvessel wall 620 adjacent to the opening 610.

When properly positioned, the apparatus 100 can be activated to deploythe closure element 500. Although preferably configured to substantiallyuniformly expand the closure element 500 beyond the naturalcross-section 530 of the closure element 500 during deployment, theapparatus 100, as desired, can deploy the closure element 500 withoutexpanding the closure element 500. The closure element 500, whendeployed, is configured to engage a significant amount of the bloodvessel wall 620 and/or tissue 630 adjacent to the opening 610. Engagingthe blood vessel wall 620 and/or tissue 630, the closure element 500 isfurther configured to return to the natural cross-section 530. Thus, theengaged blood vessel wall 620 and/or tissue 630 are drawn substantiallyclosed and/or sealed, such that, for example, hemostasis within theopening 610 is enhanced.

The apparatus 100 can be provided as one or more integrated componentsand/or discrete components. As shown in FIG. 1, for example, theapparatus 100 can comprise a locator (or obturator) assembly 200 and acarrier assembly 300. For purposes of illustration, the locator assembly200 and the carrier assembly 300 are shown in FIG. 1 as comprisingsubstantially separate assemblies. As desired, however, the locatorassembly 200 and the carrier assembly 300 each can be provided, in wholeor in part, as one or more integrated assemblies.

Being configured to extend into the opening 610, the locator assembly200 can selectably contact the inner surface 620 b of the blood vesselwall 620 adjacent the opening 610. Whereby, the locator assembly 200 isconfigured to draw the blood vessel wall 620 taut and maintain theproper position of the apparatus 100 in relation to the opening 610 asthe blood vessel 600 pulsates. The locator assembly 200 can be providedin the manner disclosed in co-pending application Ser. Nos. 09/732,835and 10/081,723, the disclosures of which are expressly incorporatedherein by reference. The locator assembly 200 preferably includes aflexible or semi-rigid tubular body 210. As illustrated in FIG. 2A, thetubular body 210 has a proximal end region 210 a and a distal end region210 b and includes a predetermined length 218 a and a predeterminedouter cross-section 218 b, both of which can be of any suitabledimension. The distal end region 210 b of the locator assembly 200preferably includes a substantially rounded, soft, and/or flexibledistal end or tip 220 to facilitate atraumatic advancement and/orretraction of the distal end region 210 b into the blood vessel 600. Asdesired, a pigtail (not shown) may be provided on the distal end 220 tofurther aid atraumatic advancement of the distal end region 210 b.

The distal end region 210 b of the locator assembly 200 further isselectably controllable between an unexpanded state and an expandedstate. In the unexpanded state, the distal end region 210 b has anunexpanded size; whereas, the distal end region 210 b in the expandedstate has an expanded size, which is greater than the unexpanded size ofthe distal end region 210 b in the unexpanded state. The distal endregion 210 b is configured to expand from the unexpanded size to theexpanded size and/or to contract from the expanded size to theunexpanded size, and the expansion and contraction of the distal endregion 210 b preferably is substantially uniform about a longitudinalaxis of the locator assembly 200. For example, one or more expansionelements 230 can be provided on the distal end region 210 b and can beconfigured to expand substantially transversely with respect to alongitudinal axis of the locator assembly 200. Preferably beingsubstantially equally distributed about an outer periphery 212 of thedistal end region 210 b, the expansion elements 230 may includeradiopaque markers (not shown) or may be wholly or partially formed froma radiopaque material to facilitate observation of the expansionelements 230 and/or the distal end region 210 b using fluoroscopy orother imaging systems.

At least one, and preferably all of the expansion elements 230 cancomprise a substantially flexible member 230′ with a substantially fixedend region 230 a′, an intermediate region 230 b′, and a movable endregion 230 c′ as shown in FIGS. 2B-C. For each substantially flexiblemember 230′, the fixed end region 230 a′ is fixedly coupled with thedistal end region 210 b; whereas, the movable end region 230 c′ ismovably coupled with the distal end region 210 b and configured to beaxially movable relative to the fixed end region 230 a′. When eachmovable end region 230 c′ is axially moved toward the relevant fixed endregion 230 a′, the intermediate regions 230 b′ buckle and/or expandtransversely outwardly, thereby transitioning the distal end region 210b of the locator assembly 200 from the unexpanded state to the expandedstate. In contrast, the distal end region 210 b transitions from theexpanded state to the unexpanded state as each of the movable endregions 230 c′ are axially moved away from the relevant fixed end region230 a′. Although the expansion elements 230 are shown as comprising theflexible members 230′ in FIGS. 2B-C for purposes of illustration, it isunderstood that the expansion elements 230 can comprise any type ofexpansion elements and are not limited to the illustrated embodiments.It is further contemplated that the expansion elements 230 may furtherinclude geometric features that allow/enhance the ability of theexpansion elements to bend or fold from a retracted position to anexpanded position. The expansion elements may be constructed of amaterial such as steel, spring steel, plastics or composites. In oneembodiment, the expansion elements are constructed of Nitinol®.

FIGS. 2B′ and 2C′ illustrate an alternative embodiment of a locatorassembly 200″ for locating a surface of a body lumen, in accordance withthe present invention. The locator assembly 200″ of this embodiment maybe functionally similar to that of the locator assembly 200 previouslydescribed above and shown in FIGS. 2B and 2C in most respects, whereincertain features will not be described in relation to this embodimentwherein those components may function in the manner as described aboveand are hereby incorporated into this alternative embodiment describedbelow. Like structures and/or components are given like referencenumerals.

The locator assembly 200″ may be located proximal to a distal end 210 b″of a tubular member 210″ and/or an apparatus (such as apparatus 100shown in FIG. 1). The locator assembly 200″ may include a surfaceengagement assembly 226″. The surface engagement assembly 226″ mayinclude a distal end portion 226 a″, a proximal end portion 226 b″,and/or at least one surface engagement element 230″. The surfaceengagement elements 230″ may be configured to transition from a relaxedstate to an expanded state, similar to the substantially flexible member230′ described above. For example, the surface engagement elements 230″may be moveably connected to and/or fixedly connected to a distal endregion 210 b″ of the locator assembly 200″. In this example, a distalend 230 a″ of the surface engagement elements 230″ may be moveablyconnected to and a proximal end 230 c″ of the surface engagementelements 230″ may be fixedly connected to the distal end region 210 b″.In other examples, other types of connections may be contemplated.

The locator assembly 200″ may include two, three, four, and/or othernumbers of surface engaging elements 230″. At least one of the surfaceengaging elements 230″ may be configured to conduct a measurablecharacteristic of the surface engaging elements 230″ to the locatorassembly 200″. For instance, the locator assembly 200″ may be incommunication with a measuring device 251. An example of a measuringdevice 251 may include an impedance measuring device, a voltmeter, anamp meter, a pressure transducer, piezoelectric crystals, othermeasuring devices, or combinations thereof. The measuring device 251 maydetermine changes in measurable characteristics of the locator assembly200″. For instance, the measuring device 251 may measure changes in theimpedance of the locator assembly 200″. In another example, themeasuring device 251 may determine changes in pressure. Changes inpressure may be determined by a pressure transducer or other pressuremeasuring device. In a further example, the measuring device 251 mayretrieve ultrasonic data in and/or around the body lumen. Ultrasonicdata may be retrieved by piezoelectric crystal or other ultrasonic datagathering device. Other measurable characteristics may includeelectrical characteristics such as voltage, current, other electricalcharacteristics, and/or other measurable characteristics.

In embodiments where the measurable characteristic is an electricalcharacteristic, the locator assembly 200″ may be in electricalcommunication with at least one of the surface engaging elements 230″.In the present embodiment, the locator assembly 200″ may include atleast one distal conductive portion 204 a″ and/or at least one proximalconductive portion 204 b″ with which at least one surface engagingelement 230″ may be in electrical communication. At least one of surfaceengaging elements 230″ may be formed at least partially from anelectrically conductive material. In the present embodiment, at leastone of surface engaging elements 230″ may be formed at least partiallyfrom Nitinol®.

The distal conductive portions 204 a″ and/or the proximal conductiveportions 204 b″ may be in electrical communication with the measuringdevice 251. For example, the at least one distal conductive portion 204a″ may be in electrical communication with the measuring device 251through at least one distal conductor connector 205 a″ and/or the atleast one proximal conductive portion 204 b″ may be in electricalcommunication with the measuring device 251 through at least oneproximal conductor connector 205 b″. The distal and/or proximalconductor connectors 205 a″, 205 b″ may extend toward the distal end 210b″ and/or toward a proximal end 210 a″ of the tubular member 210″through at least one lumen (not shown).

In the present embodiment, each of the surface engaging elements 230″may be in electrical communication with a different distal conductiveportion 204 a″ and/or proximal conductive portion 204 b″. Alternatively,more than one surface engaging element 230″ may be in electricalcommunication with the same distal conductive portion 204 a″ and/orproximal conductive portion 204 b″. Other combinations are alsocontemplated.

The surface engaging elements 230″ may be in electrical communicationwith each other. For instance, two or more surface engaging elements230″ may be may be formed from the same piece of material. In thepresent embodiment, each of the surface engaging elements 230″ may beselectively electrically isolated from each other. Isolation of thesurface engaging elements 230″ may be accomplished by insulators 206 a″,206 b″. The insulators 206 a″, 206 b″ may include materials such asceramics, polyethylene, and/or other insulating materials.

FIGS. 2B″ and 2C″ illustrate a further embodiment of a locator assembly200′″ for locating a surface of a body lumen, in accordance with thepresent invention. The locator assembly 200′″ of this embodiment may befunctionally similar to that of the locator assemblies 200, 200″previously described above and shown in FIGS. 2B-2C and 2B′-2C′ in mostrespects, wherein certain features will not be described in relation tothis embodiment wherein those components may function in the manner asdescribed above and are hereby incorporated into this alternativeembodiment described below. Like structures and/or components are givenlike reference numerals. For example, the locator assembly 200′″ may beconfigured to facilitate the determination of changes in measurablecharacteristics of the locator assembly.

The locator assembly 200′″ may be located proximal to a distal end of atubular member (such as 210 b, 210 b″ shown in FIGS. 2A, 2B, 2A′, and2B′) and/or an apparatus (such as apparatus 100 shown in FIG. 1). Thelocator assembly 200′″ may include a surface engagement assembly 226′″.

The surface engagement assembly 226′″ may include a distal end portion226 a′″, a proximal end portion 226 b′″, and/or at least one surfaceengagement element 230′″. In the present embodiment, the surfaceengagement assembly 226′″ may include four surface engagement elements230′″ that may be separated by a distal and/or proximal engagementelement support 231 a′″, 231 b′″. The distal and/or proximal engagementelement supports 231 a′″, 231 b′″ may electrically insulate the surfaceengagement elements 230′″. In an alternative embodiment, the distalengagement element supports 231 a′″, proximal engagement elementsupports 231 b′″, and/or surface engagement elements 230′″ may be formedas a unitary piece and/or from the same material. For example, thedistal engagement element supports 231 a′″, proximal engagement elementsupports 231 b′″, and/or surface engagement elements 230′″ may be lasercut from a Nitinol® tube.

The surface engagement elements 230′″ may include a distal and/orproximal retaining portion 229 a′″, 229 b′″. The distal and/or proximalretaining portions 229 a′″, 229 b′″ may include an aperture and/or otherretaining mechanism that may receive, for example, a detent and/or otherretaining mechanism. For instance, a cover member (such as the covermember 220 shown in FIG. 2C) may include a retaining mechanism (notshown) to limit motion between the cover member and the surfaceengagement elements 230′″. The cover member may be connected to acontrol member (such as control member 250 shown in FIG. 2D) that isconfigured to transition the surface engagement elements 230′″ from arelaxed state to an expanded state, similar to the substantiallyflexible member 230′ described above.

The surface engaging elements 230′″ may include a measuring component253′″. The measuring component 253′″ may facilitate the determination ofchanges in measurable characteristics of the locator assembly 200′″. Forinstance, the measuring component 253′″ may facilitate the determinationof changes in impedance, pressure, ultrasonic data, or other measurablecharacteristics. The measuring component 253′″ may be in electricalcommunication with a connector 205′″. The connector 205′″ may be inelectrical communication with a measuring device (shown as 251 in FIG.2B′).

FIGS. 2B′″ and 2C′″ illustrate a further embodiment of a locatorassembly 200′″ for locating a surface of a body lumen, in accordancewith the present invention. The locator assembly 200′″ of thisembodiment may be functionally similar to that of the locator assemblies200, 200′, 200″ previously described above and shown in FIGS. 2B-2C,2B′-2C′, and 2B″-2C″ in most respects, wherein certain features will notbe described in relation to this embodiment wherein those components mayfunction in the manner as described above and are hereby incorporatedinto this alternative embodiment described below. Like structures and/orcomponents are given like reference numerals.

The locator assembly 200″″ may be located proximal to a distal end of atubular member (such as 210 b, 210 b″ shown in FIGS. 2A, 2B, 2A′, and2B′) and/or an apparatus (such as apparatus 100 shown in FIG. 1). Thelocator assembly 200″″ may include a surface engagement assembly 226″″,a cover member 220″″, and/or a proximal end portion 226 b″″.

The cover member 220″″ and/or proximal end portion 226 b″″ may include adistal retaining portion 221 a″″ and/or a proximal retaining portion 221b″″, respectively. The surface engagement assembly 226″″ may include atleast one surface engagement element 230″″. The surface engagementelements 230″″ may include a distal and/or proximal retaining portion229 a″″, 229 b″″. The distal and/or proximal retaining portions 221 a″″,221 b″″ on the cover member 220″″ and/or proximal end portion 226 b″″may include an aperture and/or other retaining mechanism that maycooperate with corresponding distal and/or proximal retaining portions229 a″″, 229 b″″, such as a detent and/or other retaining mechanism, onthe surface engagement elements 230″″ to limit motion between the covermember 220″″, the proximal end portion 226 b″″, and/or the surfaceengagement elements 230″″. The distal and/or proximal retaining portions229 a″″, 229 b″″ may be located near a distal and/or proximal end 230a″″, 230 c″″ of the surface engagement element 230″″, respectively.

A control member 250″″ may be inserted through the proximal end portion226 b″″ and/or may be connected to the cover member 220″″. The controlmember 250″″ may be used to transition the surface engagement elements230″″ from a relaxed state to an expanded state, similar to thesubstantially flexible member 230′ described above.

In the present embodiment, the control member 250″″ may be a singlepiece, which may be elongate from the cover member 220″″ toward aproximal end (such as proximal end 210 a″ shown in FIG. 2B′) of thelocator assembly 200″″. Alternatively, the control member 250″″ may bein one or more pieces that may connected together using variousmechanisms, similar to the retaining portions 221 a″″, 221 b″″, 229 a″″,229 b″″ described above.

The proximal end portion 226 b″″ may include a tubular member retainingportion 228″″. The tubular member retaining portion 228″″ may beconfigured to engage a distal end (such as distal end 210 b, 210 b″shown in FIGS. 2B and 2B′). The tubular member retaining portion 228″″,in the present embodiment, may include a ramp and/or other retainingmechanism to limit the motion of the tubular member in at least onedirection.

The surface engagement elements 230″″ may include an engagement member232″″. The engagement member 232″″ may include an engagement portion234″″ and/or an engagement support portion 237″″.

The engagement portion 234″″ may be configured to contact and/or engagetissue. The engagement portion 234″″, in the present embodiment, may beenlarged in an intermediate portion 235″″ in comparison to distal and/orproximal end 234 a″″, 234 b″″ of the engagement portion 234″″. Anenlarged intermediate portion 235″″ may facilitate contact and/orengagement with tissue.

The engagement support portion 237″″ may support the engagement portion234″″ during, for example, transitioning from a relaxed state to anexpanded state. The engagement support portion 237″″ may include anenlarged intermediate portion 238″″, similar to the enlargedintermediate portion 235″″ of the engagement portion 234″″. Having anenlarged intermediate portion 238″″ on the engagement support portion237″″ may add stability to the engagement portion 234″″ while in theexpanded state.

The intermediate portions 235″″, 238″″ of the engagement portions 234″″and/or the engagement support portions 237″″ may be oval shaped.Alternatively, the intermediate portions 235″″, 238″″ may have the sameshape, have differing shapes, and/or have other combinations of shapes.

In the present embodiment, the proximal end 234 b″″ of the engagementportion 234″″ may be connected to a proximal support portion 233″″. Theproximal support portion 233″″ may be connected to the proximal endportion 226 b″″ and may separate the engagement portion 234″″ from theproximal end portion 226 b″″. The distal end 234 a″″ of the engagementportion 234″″ may be connected to an intermediate support portion 236″″.The intermediate support portion 236″″ may be connected to the proximalend 237 b″″ of the engagement support portion 237″″ and may separate theengagement portion 234″″ from the engagement support portion 237″″. Thedistal end 237 a″″ of the engagement support portion 237″″ may beconnected to a distal support portion 239″″. The distal support portion239″″ may be connected to the distal end (not shown) of the surfaceengagement element 230″″ and may separate the engagement support portion237″″ from the distal end portion 226 a″″.

The surface engaging elements 230″″ may include a measuring component253″″. The measuring component 253″″ may facilitate the determination ofchanges in measurable characteristics of the locator assembly 200″″. Forinstance, the measuring component 253″″ may facilitate the determinationof changes in impedance, pressure, ultrasonic data, or other measurablecharacteristics. The measuring component 253″″ may be in electricalcommunication with a connector 205″″. The connector 205″″ may be inelectrical communication with a measuring device (shown as 251 in FIG.2B′).

Referring now to FIG. 2D, the locator assembly 200 may further include alocator control system associated with the locator assembly. As shown inFIG. 2D, the locator control system 240 is associated with the proximalend region 210 a of the locator assembly 200 and is configured toselectively control the distal end region 210 b of the locator assembly200 between the unexpanded and expanded states. The locator controlsystem 240 can selectively control the distal end region 210 b betweenthe unexpanded and expanded states, such as by being activated by aswitching system (not shown). For example, a control member 250, such asa rod, wire, or other elongate member, can be moveably disposed within alumen (not shown) formed by the tubular body 210 and extendingsubstantially between the proximal end region 210 a and the distal endregion 210 b. The control member 250 has a proximal end region 250 athat is coupled with the locator control system 240, preferably via acontrol block 260 (shown in FIG. 4D), and a distal end region (notshown) that is coupled with the distal end region 210 b of the locatorassembly 200, the expansion elements 230, and/or the movable end regions230 c′ of the substantially flexible members 230′. The locator controlsystem 240 can selectively transition the distal end region 210 b, theexpansion elements 230, and/or the substantially flexible members 230′between the unexpanded and expanded states by moving the control member250 axially relative to the tubular body 210.

The locator control system 240 further includes a locator release system490 for maintaining the unexpanded state and/or the expanded state ofthe distal end region 210 b, the expansion elements 230, and/or thesubstantially flexible members 230′. Preferably being configured tomaintain the expanded state of the distal end region 210 b, the locatorrelease system 490 can comprise any type of locking system and can beengaged, for instance, by activating the switching system. For example,once the substantially flexible members 230′ have entered the expandedstate, the locator release system 490 can secure the control member 250to prevent axial movement relative to the tubular body 210, therebymaintaining the substantially flexible members 230′ in the expandedstate.

In the manner described in more detail below, the locator control system240 also can be configured to disengage the locator release system 490,such that the distal end region 210 b, the expansion elements 230,and/or the substantially flexible members 230′ can transition betweenthe expanded and unexpanded states. The locator release system 490 canbe disengaged, for example, by activating an emergency release system(not shown). As desired, the locator control system 240 may furtherinclude a biasing system (not shown), such as one or more springs orother resilient members, to bias the distal end region 210 b, theexpansion elements 230, and/or the substantially flexible members 230′to enter and/or maintain the unexpanded state when the locator releasesystem 490 is disengaged.

Returning to FIG. 1, the carrier assembly 300 is coupled with, andslidable relative to, the locator assembly 200. The carrier assembly 300is configured to receive and retain the closure element 500 (shown inFIGS. 6A-B), which preferably is disposed substantially within thecarrier assembly 300. When the locator assembly 200 engages the innersurface 620 b (shown in FIG. 8A) of the blood vessel wall 620 (shown inFIG. 8A), the carrier assembly 300 is further configured to position theclosure element 500 substantially adjacent to the opening 610 (shown inFIG. 8A) and to deploy the closure element 500. Upon being deployed, theclosure element 500 can maintain the reduced cross-section 530′ (shownin FIGS. 6C-D) but preferably can temporarily and substantiallyuniformly expand beyond the natural cross-section 530 (shown in FIGS.6A-B) of the closure element 500. In either case, the closure element500, when deployed, can engage a significant amount of the blood vesselwall 620 and/or tissue 630 adjacent to the opening 610. Thereafter, theclosure element 500 is configured to return to the natural cross-section530, preferably substantially uniformly, such that the blood vessel wall620 and/or tissue 630 is drawn substantially closed and/or sealed.

Turning to FIGS. 3A-D, the carrier assembly 300 can include a tube set305, comprising a carrier member 310, a pusher member 320, a supporttube 340, and a cover member 330. The carrier member 310, the pushermember 320, the support tube 340, and the cover member 330 can beprovided as a plurality of nested, telescoping members with a commonlongitudinal axis 350 as illustrated in FIG. 3A. The carrier member 310is configured to receive and support the closure element 500. Whilebeing disposed on the carrier member 310, the closure element 500preferably is deformed from the natural, planar configuration to formthe substantially tubular closure element 500″ (shown in FIGS. 6F-G) aswill be discussed in more detail below. Being disposed substantiallyabout, and supported by, an outer periphery 312 b of the carrier member310, the substantially tubular closure element 500″ can be substantiallyin axial alignment with the carrier member 310 with the tines 520pointed substantially distally.

Preferably being formed as a substantially rigid, semi-rigid, orflexible tubular member, the carrier member 310 has a proximal endregion 310 a and a distal end region 310 b and includes a predeterminedlength 318 a and a predetermined cross-section 318 b, both of which canbe of any suitable dimension. The carrier member 310 also can define alumen 314 that extends substantially between the proximal end region 310a and the distal end region 310 b and that is configured to slidablyreceive at least a portion of the tubular body 210 of the locatorassembly 200. Although the cross-section 318 b of the carrier member 310generally is substantially uniform, the distal end region 310 b of thecarrier member 310 preferably has a cross-section that increasesdistally, as illustrated in FIGS. 3A-B, for substantially uniformlyexpanding the substantially tubular closure element 500″ beyond thenatural cross-section 530 of the closure element 500 when thesubstantially tubular closure element 500″ is deployed. To deploy theclosure element 500 without expanding the closure element 500, thedistal end region 310 b can be formed with a cross-section (not shown)that is substantially uniform. Although shown and described as havingthe cross-section that increases distally for expanding thesubstantially tubular closure element 500″, it will be understood thatthe distal end region 310 b of the carrier member 310 can be providedwith the substantially-uniform cross-section and that the substantiallytubular closure element 500″ can be deployed without being expanded.

Being configured to distally deploy the substantially tubular closureelement 500″, the pusher member 320 has a proximal end region 320 a anda distal end region 320 b and is coupled with, and slidable relative to,the carrier member 310. The pusher member 320 includes a predeterminedlength 328 a and a predetermined cross-section 328 b, both of which canbe of any suitable dimension and can be configured to slidably receivethe carrier member 310 such that the distal end region 320 b of thepusher member 320 is offset proximally from the distal end region 310 bof the carrier member 310. As desired, the predetermined length 328 a ofthe pusher member 320 can be greater than or substantially equal to thepredetermined length 318 a of the carrier member 310. The predeterminedlength 328 a of the pusher member 320 however is preferably less thanthe predetermined length 318 a of the carrier member 310 such that thecarrier member 310 and the pusher member 320 at least partially define aspace 360 distal to the distal end region 320 b of the pusher member 320and along the periphery 312 b of the carrier member 310.

Being formed from a substantially rigid, semi-rigid, or flexiblematerial, the pusher member 320 preferably is substantially tubular andcan define a lumen 324 that extends substantially between the proximalend region 320 a and the distal end region 320 b and that is configuredto slidably receive at least a portion of the carrier member 310. Thecross-section 328 b of the pusher member 320 preferably is substantiallyuniform, and the distal end region 320 b of the pusher member 320 cancomprise one or more longitudinal extensions 325, which extend distallyfrom the pusher member 320 and along the periphery 312 b of the carriermember 310 as shown in FIG. 3C. The longitudinal extensions 325preferably are biased such that the longitudinal extensions 325 extendgenerally in parallel with common longitudinal axis 350. Thelongitudinal extensions 325 are sufficiently flexible to expandradially, and yet sufficiently rigid to inhibit buckling, as the distalend region 320 b is directed distally along the carrier member 310 andengage the distally-increasing cross-section of the distal end region310 b of the carrier member 310 to deploy the substantially tubularclosure element 500″.

A cover member 330 is configured to retain the substantially tubularclosure element 500″ substantially within the carrier assembly 300 priorto deployment as shown in FIG. 3D. Being coupled with, and slidablerelative to, the pusher member 320, the cover member 330 has a proximalend region 330 a and a distal end region 330 b and includes apredetermined length 338 a and a predetermined cross-section 338 b, bothof which can be of any suitable dimension. Preferably being formed as asubstantially rigid, semi-rigid, or flexible tubular member, the covermember 330 has an inner periphery 332 a and an outer periphery 332 b andcan define a lumen 334. The lumen 334 extends substantially between theproximal and distal end regions 330 a, 330 b of the cover member 330 andcan be configured to slidably receive at least a portion of the pushermember 320. When the cover member 330 is properly positioned within thecarrier assembly 300, the distal end region 330 b is configured toextend over the space 360, thereby defining an annular cavity 370 forreceiving and retaining the substantially tubular closure element 500″.

The cross-section 338 b of the cover member 330 preferably issubstantially uniform, and the distal end region 330 b of the covermember 330 preferably comprises one or more longitudinal extensions 335,which extends distally from the cover member 330 and along an outerperiphery 322 b of the pusher member 320 as shown in FIG. 3D. Althoughthe longitudinal extensions 335 can extend generally in parallel withcommon longitudinal axis 350, the longitudinal extensions 335 preferablyare biased such that the plurality of longitudinal extensions 335 extendsubstantially radially inwardly as illustrated in FIGS. 3A and 3D.Thereby, the longitudinal extensions 335 can at least partially closethe lumen 334 substantially adjacent to the distal end region 330 b ofthe cover member 330. To permit the substantially tubular closureelement 500″ to be deployed from the annular cavity 370, thelongitudinal extensions 335 preferably are sufficiently flexible toexpand radially to permit the distal end region 310 b of the carriermember 310 to move distally past the cover member 330 to open theannular cavity 370 such that the distal end region 330 b no longerextends over the space 360.

If the carrier assembly 300 is assembled as the plurality of nested,telescoping members as shown in FIG. 3A, the carrier member 310 is atleast partially disposed within, and slidable relative to, the lumen 324of the pusher member 320 as shown in FIG. 3C. The pusher member 320, inturn, is at least partially disposed within, and slidable relative to,the lumen 334 of the cover member 330. To couple the carrier assembly300 with the locator assembly 200, the tubular body 210 of the locatorassembly 200 is at least partially disposed within, and slidablerelative to, the lumen 314 of the carrier member 310. The longitudinalaxis of the locator assembly 200 is preferably substantially in axialalignment with the common longitudinal axis 350 of the carrier member310, the pusher member 320, the cover member 330, and the support tube340.

It will be appreciated that the tube set 305 preferably also includes asupport member 340 as shown in FIGS. 3A and 3E. The support member 340is configured to slidably receive the tubular body 210 of the locatorassembly 200 and to provide radial support for the distal end region 210b of the tubular body 210 when the locator assembly 200 is coupled withthe carrier assembly 300. The carrier assembly 300 can advantageouslyinclude the support member 340, for example, if the tubular body 210 isnot sufficiently rigid or under other circumstances in which support forthe tubular body 210 might be desirable. It also will be appreciatedthat the support member 340 also can be configured to inhibit theplurality of longitudinal extensions 335, which extend from the distalend region 330 b of the cover member 330, from expanding prematurelyprior to the closure element 500 being deployed.

The support member 340 is preferably formed as a substantially rigid,semi-rigid, or flexible tubular member, having a proximal end region 340a and a distal end region 340 b. Wherein an outer periphery 342 b of thesupport member 340 can define a lumen 344 that extends substantiallybetween the proximal end region 340 a and the distal end region 340 b,the lumen is configured to slidably receive and support at least aportion of the tubular body 210 of the locator assembly 200. The supportmember 340, in turn, can be at least partially slidably disposed withinthe lumen 314 of the carrier member 310 such that the tubular body 210of the locator assembly 200 may be coupled with, and slidable relativeto, the carrier member 310 in the manner described in more detail above.The support member 340 has a predetermined length 348 a and apredetermined cross-section 348 b, both of which can be of any suitabledimension, and the cross-section 348 b preferably is substantiallyuniform. Although shown and described as being substantially separatefor purposes of illustration, it will be appreciated that the carriermember 310, the pusher member 320, the cover member 330, and/or thesupport member 340 can be provided, in whole or in part, as one or moreintegrated assemblies.

The carrier assembly 300 may further include a housing 380 asillustrated in FIG. 4A. Preferably being formed as an elongate memberwith a longitudinal axis 386, the housing 380 has an outer periphery 382b and includes a proximal end region 380 a and a distal end region 380b. Thereby, when the apparatus 100 is properly assembled, the tubularbody 210 of the locator assembly 200 at least partially disposed withinthe tube set 305 such that the distal end region 210 b of the tubularbody 210 extends beyond the distal end regions 310 b, 320 b, 330 b,and/or 340 b. The tubular body 210, the carrier member 310, the pushermember 320, the cover member 330, and, if provided, the support member340 is at least partially disposed within, and slidable relative to, thehousing 380, and the respective distal end regions 210 b, 310 b, 320 b,330 b, and 340 b extend from the distal end region 380 b of the housing380 such that the common longitudinal axis 350 (shown in FIG. 3A) of thetube set 305 is substantially axially aligned with the longitudinal axis386 of the housing 380. Being configured to slidably retain therespective proximal end regions 210 a, 310 a, 320 a, 330 a, and 340 a,the housing 380 supports the tube set 305 and can have one or morehandles 390 to facilitate use of the apparatus 100. The handles 390extend substantially radially from the outer periphery 382 b of thehousing 380 and can be provided in the manner known in the art.

When the apparatus 100 is properly assembled, the tubular body 210 ofthe locator assembly 200 is at least partially disposed within the tubeset 305 of the carrier assembly 300 such that the distal end region 210b of the tubular body 210 extends beyond the distal end regions 310 b,320 b, 330 b, and/or 340 b. Further, the proximal end region 210 a ofthe tubular body 210 and the proximal end regions 310 a, 320 a, 330 a,and/or 340 a of the tube set 305 are at least partially disposed within,and slidable relative to, the housing 380. The switching system of thelocator assembly 200 and a switching system 450 of the triggering system400 preferably are accessible external to the housing 380 as shown inFIGS. 4A and 4C.

Turning to FIGS. 4B-D, a triggering system 400 can be disposedsubstantially within the housing 380. The triggering system 400 isconfigured to control the relative axial movement and/or positioning ofthe respective distal end regions 310 b, 320 b, 330 b, and 340 b of thetube set 305 and/or the distal end region 210 b of the locator assembly200. Being coupled with the proximal end regions 210 a, 310 a, 320 a,330 a, and/or 340 a, the triggering system 400 can control the relativeaxial movement of the distal end regions 210 b, 310 b, 320 b, 330 b,and/or 340 b in any manner, such as by being activated by the switchingsystem 450. As desired, the triggering system 400 can induce axialmotion, such as distal motion, with respect to one or more of the distalend regions 210 b, 310 b, 320 b, 330 b, and/or 340 b. One or more of thedistal end regions 210 b, 310 b, 320 b, 330 b, and/or 340 b can beaxially moved. Axial motion of one or more of the carrier member 310,the pusher member 320, the cover member 330, and the support member 340and/or the tubular body 210 can be attained, for example, by applying anaxial force to the switching system 450. To facilitate monitoring of thepositioning of the carrier assembly 300 and/or the substantially tubularclosure element 500″, one or more of the distal end regions 210 b, 310b, 320 b, 330 b, and/or 340 b may include radiopaque markers (not shown)or may be wholly or partially formed from a radiopaque material.

The triggering system 400 is configured to overcome internal resistancesuch that the relative axial movement and/or positioning of therespective distal end regions 310 b, 320 b, 330 b, and 340 b of the tubeset 305 and/or the distal end region 210 b of the locator assembly 200are controlled in accordance with a predetermined manner when thetriggering system 400 is activated. Thereby, movement and/or positioningof the distal end regions 310 b, 320 b, 330 b, 340 b, and/or 210 b isinitiated when at least a predetermined quantity of force is applied tothe switching system 450. Stated somewhat differently, a force that isless than the predetermined quantity generally is insufficient toactivate the triggering system 400; whereas, when the force increases toa level that is greater than or substantially equal to the predeterminedquantity, the triggering system 400 is configured to activate, moveand/or position the distal end regions 310 b, 320 b, 330 b, 340 b,and/or 210 b in accordance with the predetermined manner. The triggeringsystem 400, once activated, preferably continues to move and/or positionthe distal end regions 310 b, 320 b, 330 b, 340 b, and/or 210 b inaccordance with the predetermined manner until the closure element 500is deployed.

The triggering system 400, for example, can comprise one or more sets ofcooperating detents for coupling the axial motion of the distal endregions 310 b, 320 b, 330 b, and 340 b in accordance with apredetermined manner when the triggering system 400 is activated. Theterm “detents” refers to any combination of mating elements, such asblocks, tabs, pockets, slots, ramps, locking pins, cantilevered members,support pins, and the like, that may be selectively or automaticallyengaged and/or disengaged to couple or decouple the carrier member 310,the pusher member 320, the cover member 330, and the support member 340relative to one another. It will be appreciated that the cooperatingdetents as illustrated and described below are merely exemplary and notexhaustive. For example, the cooperating detents can include a first setof cooperating blocks and pockets for releasably coupling the supportmember 340, the carrier member 310, the pusher member 320, and the covermember 330. When the carrier assembly 300 reaches a first predetermineddistal position, the support member 340 can be decoupled from thecarrier member 310, the pusher member 320, and the cover member 330 andpreferably is substantially inhibited from further axial movement.Thereby, the carrier member 310, the pusher member 320, and the covermember 330 may continue to be directed distally as the support member340 remains substantially stationary.

As shown in FIGS. 4B-C, the cooperating detents can comprise a carrierblock 410, a pusher block 420, a cover block 430, and a support block440, which can be configured to couple and decouple in accordance withthe predetermined manner. For example, the carrier block 410 is disposedon the proximal end region 310 a of the carrier member 310 and includesa carrier pin 412 c that extends from the carrier block 410; whereas,the proximal end region 330 a of the cover member 330 and the proximalend region 340 a the support member 340 are respectively coupled withthe cover block 430 and the support block 440. A cover pin 432 b extendsfrom the cover block 430, and the support block 440 has a support pin442 a, which extends from the support block 440. The support pin 442 a,the cover pin 432 b, and the carrier pin 412 c each preferably areformed from a substantially rigid material, such as an alloy ofnickel-titanium.

The pusher block 420 is disposed on the proximal end region 320 a of thepusher member 320 and forms a support slot 422 a, a cover slot 422 b,and a carrier slot 422 c. The support slot 422 a is configured toreceive and releasable engage the support pin 442 a by which the supportmember 340 can be coupled with, and decoupled from, the pusher member320. The cover member 330 can be coupled with, and decoupled from, thepusher member 320 via the cover slot 422 b, which is configured toreceive and releasable engage the cover pin 432 b. The carrier slot 422c is configured to receive and releasable engage the carrier pin 412 csuch that the carrier member 310 can be coupled with, and decoupledfrom, the pusher member 320. The carrier block 410, the pusher block420, the cover block 430, and the support block 440 preferably arerespectively disposed substantially on the outer peripheries 312 b, 322b, 332 b, and 342 b and can be configured to couple and decouple inaccordance with the predetermined manner.

The triggering system 400 further includes one or more stops forengaging the pusher block 420, the cover block 430, and/or the supportblock 440, respectively. As illustrated in FIG. 4B, a support stop 460a, a cover stop 460 b, and a carrier stop 460 c each are formed in thehousing 380 and are configured to receive, and substantially inhibitfurther movement of, the support block 440, the cover block 430, and thecarrier block 410, respectively, in accordance with the predeterminedmanner. For example, when an axial force is applied to the tube set 305via the switching system 450, the cover block 430 moves distally withinthe housing 380, and the cover block 430 approaches the cover stop 460b. Upon being received by the cover stop 460 b, the cover block 430 issubstantially locked in place, substantially preventing any furthermotion of the cover block 430.

Resisting the axial force, the cover pin 432 b provides a static loadwhile the axial force is less than the predetermined quantity of force.As the axial force increases to a level that is greater than orsubstantially equal to the predetermined quantity, the cover pin 432 bis displaced from the cover slot 422 b, decoupling the cover member 330from the carrier member 310, the pusher member 320, and the supportmember 340. Creating the internal resistance to be overcome by thetriggering system 400, the static forces provided by the pins 442 a, 432b, and 412 c is approximately proportional to a composition andcross-section of the respective pins 442 a, 432 b, and 412 c and/or adepth and a slope of the respective slots 422 a, 422 b, and 422 c. Asdesired, the pins 442 a, 432 b, and 412 c can be configured to providestatic loads that are differing and/or substantially uniform.

Turning to FIG. 4D, the triggering system 400 may further include a tuberelease system 470 for inhibiting inadvertent advancement of the tubeset 305. The tube release system 470 is coupled with a tube releasemember 480, such as a rod, wire, or other elongate member. The tuberelease member 480 has a proximal end region 480 a that is disposedsubstantially between the pusher block 420 and the housing 380 (shown inFIG. 4A) and a distal end region 480 b that is coupled with the tuberelease system 470. Preferably, a tab 485 is coupled with the proximalend region 480 a of the tube release member 480, and a pin (not shown)extends from the pusher block 420 and is disposed substantially betweenthe tab 485 and a groove (not shown) formed in the housing 380. The tuberelease system 470 is configured to release the tube set 305 when thetube release member 480 is moved proximally, freeing the pusher block420.

A locator release system 490 for permitting the distal end region 210 b,the expansion elements 230, and/or the substantially flexible members230′ of the locator assembly 200 to transition from the expanded stateto the unexpanded state can be included with the triggering system 400.The locator release system 490 can comprise a rod, wire, or otherelongate member and has a proximal end region 490 a and a distal endregion 490 b. The proximal end region 490 a of the locator releasesystem 490 can be coupled with, and configured to activate, the locatorcontrol system (shown in FIG. 2D), and the distal end region 490 bextends beyond the pusher block 420. Thereby, when the pusher block 420is advanced during deployment of the closure element 500, the controlblock 260 is disengaged such that the distal end region 210 b, theexpansion elements 230, and/or the substantially flexible members 230′of the locator assembly 200 to transition from the expanded state to theunexpanded state.

The operation of the triggering system 400 in accordance with onepredetermined manner is illustrated in FIGS. 5A-C with the closureelement 500 (shown in FIGS. 6A-B) disposed substantially within theapparatus 100. As shown in FIG. 5A, the distal end region 210 b of thelocator assembly 200 has been positioned as desired and has transitionedfrom the unexpanded state to the expanded state. While the locatorcontrol system 240 (shown in FIG. 2D) maintains the distal end region210 b in the expanded state, a distally-directed axial force is appliedto the triggering system 400 via the switching system 450. Once the tuberelease member 480 (shown in FIG. 4D) has been moved proximally to freethe pusher block 420, the tube set 305 is substantially freely slidablewithin the housing 380 and responds to the axial force by slidingdistally from an initial predetermined position to a first predeterminedposition.

In the initial predetermined position, the carrier member 310, thepusher member 320, the cover member 330, and the support member 340 arecoupled via the slots 422 c, 422 b, and 422 a (shown in FIG. 4C) and thepins 412 c, 432 b, and 442 a (shown in FIG. 4C). Stated somewhatdifferently, the support pin 442 a, the cover pin 432 b, and the carrierpin 412 c are respectively disposed within, and engaged by, the supportslot 422 a, the cover slot 422 b, and the carrier slot 422 c such thatthe carrier block 410, the pusher block 420, the cover block 430, andthe support block 440 are coupled as illustrated in FIG. 4C. Therefore,the carrier member 310, the pusher member 320, the cover member 330, andthe support member 340 each slide distally from the initialpredetermined position to the first predetermined position in responseto the axial force.

FIG. 5B illustrates the positions of the carrier member 310, the pushermember 320, the cover member 330, and the support member 340 uponreaching the first predetermined position. In the first predeterminedposition, the support block 440 and the cover block 430 respectivelyengage the support stop 460 a and the cover stop 460 b. Thereby, thesupport stop 460 a receives, and substantially inhibits further movementof, the support block 440 and, therefore, the support member 340;whereas, the cover stop 460 b receives, and substantially inhibitsfurther movement of, the cover block 430 and, therefore, the covermember 330. Although the support block 440 and the cover block 430preferably engage the support stop 460 a and the cover stop 460 b in thefirst predetermined position, it will be appreciated that the supportblock 440 can engage the support stop 460 a and the cover block 430 canengage the cover stop 460 b in different predetermined positions. Inother words, the predetermined manner can comprise any number ofpredetermined positions, each predetermined position being associatedwith any number of the blocks 410, 420, 430, and 440 engaging any numberof relevant stops 460 a, 460 b, and 460 c.

To continue distally from the first predetermined position, the carriermember 310 and the pusher member 320 can be decoupled from the covermember 330 and the support member 340 by disengaging the support pin 442a and the cover pin 432 b from the support slot 422 a and the cover slot422 b, respectively. In the manner described in more detail above withreference to FIGS. 4B-C, the support pin 442 a and the cover pin 432 beach resist the axial force. While the axial force is less than thecombined static force provided by the support pin 442 a and the coverpin 432 b, the carrier member 310 and the pusher member 320 remaincoupled with the cover member 330 and the support member 340. As theaxial force increases to a level that is greater than or substantiallyequal to the combined static force, the support pin 442 a and the coverpin 432 b are respectively displaced from the support slot 422 a and thecover slot 422 b, decoupling the carrier member 310 and the pushermember 320 from the cover member 330 and the support member 340.Thereby, the cover member 330 and the support member 340 preferably areinhibited from further distal movement and remain substantiallystationary; whereas, the carrier member 310 and the pusher member 320proceed distally toward a second predetermined position.

The pusher member 320 and the carrier member 310 continue distally untilthe second predetermined position is reached as shown in FIG. 5C. In thesecond predetermined position, the carrier block 410 engages the carrierstop 460 c. Whereby, the carrier stop 460 c receives, and substantiallyinhibits further movement of, the carrier block 410 and, therefore, thecarrier member 310. To continue distally from the second predeterminedposition, the pusher member 320 can be decoupled from the carrier member310 by disengaging the carrier pin 412 c from the carrier slot 422 c. Inthe manner described in more detail above with reference to FIGS. 4B-C,the carrier pin 412 c resists the axial force. While the axial force isless than the static force provided by the carrier pin 412 c, the pushermember 320 remains coupled with the carrier member 310.

As the axial force increases to a level that is greater than orsubstantially equal to the static force, the carrier pin 412 c isdisplaced from the carrier slot 422 c, decoupling the pusher member 320from the carrier member 310. Thereby, the carrier member 310 preferablyis inhibited from further distal movement and remains substantiallystationary; whereas, the pusher member 320 proceeds distally to deploythe closure element 500 and to activate the locator release system 490(shown in FIG. 4D) such that the distal end region 210 b, the expansionelements 230, and/or the substantially flexible members 230′ of thelocator assembly 200 transition from the expanded state to theunexpanded state. Preferably, the axial force that is applied toovercome the static force associated with the first predeterminedposition is sufficient to overcome the static forces associated with thesubsequent predetermined positions, to deploy the closure element 500,and to activate the locator release system 490 such that the triggeringsystem 400 operates in one substantially-continuous motion.

It will be appreciated that the triggering system 400 can include anenergy storing element (not shown), which can be disposed substantiallybetween the housing 380 and the blocks 410, 420, 430, and 440 and whichis configured to store potential energy for moving the tube set 305 fromthe initial predetermined position through the other predeterminedpositions, deploying the closure element 500, and/or activating thelocator release system 490. The energy-storing element is configuredstore the potential energy when the tube set 305 is in the initialpredetermined position and to release the potential energy, whenactivated, such that the tube set 305 travels through the predeterminedpositions at a substantially constant and continuous rate. For example,the energy-storing element can comprise one or more springs (not shown).Each of the springs can be in a compressed state when the tube set 305is in the initial predetermined position and released from thecompressed state when the switching system 450 of the triggering system400 is activated.

In use, the closure element 500 is disposed within the carrier assemblyand adjacent to the distal end of the pusher tube 320. As shown in FIGS.7A-B, for example, the reduced closure element 500′ can be slidablyreceived over the distally-increasing cross-section 318 b of the distalend region 310 b of the carrier member 310 and disposed about theperiphery 312 of the carrier member 310 adjacent to the space 360. Sincethe reduced cross-section 530′ of the reduced closure element 500′ isless than the cross-section 318 b of the distally-increasingcross-section 318 b, the reduced closure element 500′ must betemporarily radially deformed to be received over the distal end region310 b. Also, as the reduced closure element 500′ is received over thedistal end region 310 b, the opposing tines 520 of the reduced closureelement 500′ engages the distal end region 310 b. The reduced closureelement 500′ thereby forms the substantially tubular closure element500″ in the manner described in more detail above with reference toFIGS. 6E-G.

After being received over the distal end region 310 b, the substantiallytubular closure element 500″ is disposed about the space 360, and thetines 520 are directed substantially distally as shown in FIG. 7B. Asdesired, one or more of the tines 520 can be disposed proximally of thedistally-increasing cross-section 318 b of the distal end region 310 b,as illustrated in FIG. 7B, and/or can be at least partially disposedupon, and contact, the distally-increasing cross-section 318 b of thedistal end region 310 b. To improve the engagement between the closureelement 500 (shown in FIGS. 6A-B) and the blood vessel wall 620 and/ortissue 630 (collectively shown in FIG. 8A), the substantially tubularclosure element 500″ preferably is disposed on the carrier member 310such that the tines 520 define a first plane that is substantiallyperpendicular to a second plane defined by the switching system 450and/or the handles 390 (collectively shown in FIG. 5A).

Once disposed about the space 360, the substantially tubular closureelement 500″ can be retained on the outer periphery 312 b of the carriermember 310 when distal end region 310 b of the carrier member 310 andthe distal end region 320 b of the pusher member 320 are slidablyreceived within the lumen 334 of the cover member 330 as illustrated inFIGS. 7C-D. When the cover member 330 is properly positioned within thecarrier assembly 300, the distal end region 330 b of the cover member330 extends over the space 360 and defines the annular cavity 370 forretaining the substantially tubular closure element 500″. As such, thesubstantially tubular closure element 500″ is disposed substantiallybetween the outer periphery 312 b of the carrier member 310 and theinner periphery 332 a of the cover member 330 such that thesubstantially tubular closure element 500″ maintains the substantiallytubular configuration with the tines 520 being directed substantiallydistally. As desired, the cover member 330 may radially compress thesubstantially tubular closure element 500″ such that the substantiallytubular closure element 500″ enters and maintains a compressed tubularconfiguration. The body 510 of the substantially tubular closure element500″ can be disposed distally of the distal end region 320 b of thepusher member 320, as illustrated in FIGS. 7C-D, or can engage thedistal end region 320 b, as desired.

FIGS. 8A-8L illustrate an embodiment of a method for accessing a bodylumen and/or delivering a closure element. The method may incorporatevarious components of the apparatuses described herein. For example,various locator assemblies (such as locator assembly 200, 200′, 200″,200′″, 200″″ shown in FIGS. 2A, 2B, 2A′, 2B′, 2A″, 2B″, 2A′″, and 2B′″,respectively) may be used with the present embodiment. For ease ofdescription, the method will be described with the locator assembly 200shown in FIGS. 2A and 2B. However, it will be understood that otherlocator assembly embodiments may be used.

As shown in FIG. 8A, a sheath 640 may be inserted or otherwisepositioned through skin 650 and tissue 630 and within the blood vessel600 or other body lumen via the opening 610. Comprising a substantiallyflexible or semi-rigid tubular member, the sheath 640 has a proximal endregion 640 a and a distal end region 640 b and includes a predeterminedlength and a predetermined cross-section, both of which can be of anysuitable dimension. The sheath 640 also forms a lumen 644 that extendsalong a longitudinal axis of the sheath 640 and substantially betweenthe proximal and distal end regions 640 a, 640 b. The lumen 644 can haveany suitable internal cross-section 648 b and is suitable for receivingone or more devices (not shown), such as a catheter, a guide wire, orthe like. The lumen 644 is configured to slidably receive a tubular body210 of the locator assembly 200 and/or the tube set 305 of the carrierassembly 300 (shown in FIG. 4A).

Since the internal cross-section 648 b of the sheath 640 typically isless than or substantially equal to the predetermined cross-section 338b of the cover member 330, the sheath 640 may be configured to radiallyexpand, such as by stretching, to receive the tube set 305.Alternatively, or in addition, the sheath 640 can be advantageouslyconfigured to split as the tube set 305 is received by, and advanceswithin, the lumen 644 of the sheath 640, thereby permitting theapparatus 100 to access the blood vessel wall 620. To facilitate thesplitting, the sheath 640 can include one or more splits 645, such aslongitudinal splits, each split being provided in the manner known inthe art. Each split 645 is configured to split the sheath 640 inaccordance with a predetermined pattern, such as in a spiral pattern. Itwill be appreciated that, when the internal cross-section 648 b of thesheath 640 is greater than the predetermined cross-section 338 b of thecover member 330, it may not be necessary for the sheath 640 to beconfigured to radially expand and/or split. In addition to, or as analternative to, the apparatus 100 may include a cutting means thatinitiates a tear line or split in the sheath when the sheath is engagedwith the distal end of the apparatus 100.

The sheath 640 may be advanced over a guide wire or other rail (notshown) which has been positioned through the opening 610 and into theblood vessel 600 using conventional procedures such as those describedabove. Preferably, the blood vessel 600 is a peripheral blood vessel,such as a femoral or carotid artery, although other body lumens may beaccessed using the sheath 640. The opening 610, and consequently thesheath 640, may be oriented with respect to the blood vessel 600 such asto facilitate the introduction of devices through the lumen 644 of thesheath 640 and into the blood vessel 600 with minimal risk of damage tothe blood vessel 600. One or more devices (not shown), such as acatheter, a guide wire, or the like, may be inserted through the sheath640 and advanced to a preselected location within the patient's body.For example, the devices may be used to perform a therapeutic ordiagnostic procedure, such as angioplasty, atherectomy, stentimplantation, and the like, within the patent's vasculature.

After the procedure is completed, the devices are removed from thesheath 640, and the apparatus 100 is prepared to be received by thelumen 644 of the sheath 640 as shown in FIG. 8B. Being in the unexpandedstate, the distal end region 210 b of the tubular body 210 of thelocator assembly 200 is slidably received by the lumen 644 andatraumatically advanced distally into the blood vessel 600 asillustrated in FIGS. 8B-C. Once the distal end region 210 b of thetubular body 210 extends into the blood vessel 600, the distal endregion 210 b can transition from the unexpanded state to the expandedstate as shown in FIG. 8D by activating the switching system of thelocator assembly 200.

In some embodiments, the locator assembly 200 may be in communicationwith a measuring device 251. In these embodiments, a measurement of ameasurable characteristic may be taken while the locator assembly 200 ispositioned within the body lumen (i.e. blood vessel 600). For example,an impedance measurement may be taken within the body lumen. Themeasurement may be taken with the distal end 210 b in the expandedstate.

Turning to FIG. 8E, the apparatus 100 and the sheath 640 then areretracted proximally until the distal end region 210 b is substantiallyadjacent to an inner surface 620 b of the blood vessel wall 620. Thedistal end region 210 b thereby draws the blood vessel wall 620 taut andmaintains the proper position of the apparatus 100 as the blood vessel600 pulsates. Since the expanded cross-section of the distal end region210 b is greater than or substantially equal to the cross-section of theopening 610 and/or the cross-section of the lumen 644, the distal endregion 210 b remains in the blood vessel 600 and engages the innersurface 620 b of the blood vessel wall 620. The distal end region 210 bcan frictionally engage the inner surface 620 b of the blood vessel wall620, thereby securing the apparatus 100 to the blood vessel 600. Thesheath 640 is retracted proximally such that the distal end region 640 bof the sheath 640 is substantially withdrawn from the blood vessel 600,as shown in FIG. E, permitting the apparatus 100 to access the bloodvessel wall 620.

A second measurement of a measurable characteristic may be taken. Thesecond measurement may be taken after proximally retracting theapparatus 100. The first measurement and the second measurement may becompared to determine whether the locator assembly 200 has contactedtissue of the body lumen (i.e. the inner surface 620 b of the bloodvessel wall 620). Alternatively, the apparatus 100 may be retractedproximally until a measurable characteristic is within a predeterminedrange of the first measurement. For example, a predetermined range ofimpedance differences may be used to determine whether the locatorassembly 200 has contacted the tissue of the body lumen. The technicianmay be notified that the measurable characteristic is within thepredetermined range of the first measurement by, for example, a light,buzzer, and/or other notification method.

As the apparatus 100 is being retracted, the apparatus 100 preferablyalso is axially rotated such that the first plane defined by the tines520 of the substantially tubular closure element 500″ is substantiallyparallel with a third plane defined by the blood vessel 600. Thereby,the engagement between the substantially tubular closure element 500″and the blood vessel wall 620 and/or tissue 630 can be improved becausethe tines 520 are configured to engage the blood vessel wall 620 and/ortissue 630 at opposite sides of the opening 610. If the substantiallytubular closure element 500″ is disposed on the carrier member 310 suchthat the first plane defined by the tines 520 is substantiallyperpendicular to the second plane defined by the switching system 450and/or the handles 390 (collectively shown in FIG. 5A), for example, theapparatus 100 can be positioned such that the second plane defined bythe switching system 450 and/or the handles 390 is substantiallyperpendicular to the third plane defined by the blood vessel 600.

Once the distal end region 210 b of the locator assembly 200 contactsthe inner surface 620 b of the blood vessel wall 620, the tube set 305can then be advanced distally and received within the lumen 644 of thesheath 640 as illustrated in FIG. 8F. In the manner described in moredetail above with reference to FIG. 8A, the sheath 640 can radiallyexpand and/or split in accordance with the predetermined pattern as thetube set 305 advances because the internal cross-section 648 b of thesheath 640 is less than or substantially equal to the predeterminedcross-section 338 b of the cover member 330. Being coupled, the carriermember 310, the pusher member 320, the cover member 330, and the supportmember 340 each advance distally and approach the first predeterminedposition as illustrated in FIG. 8G.

Upon reaching the first predetermined position, the tube set 305 isdisposed substantially adjacent to the outer surface 620 a of the bloodvessel wall 620 adjacent to the opening 610 such that the blood vesselwall 620 adjacent to the opening 610 is disposed substantially betweenthe expanded distal region 210 b of the locator assembly 200 and thetube set 305. The cover member 330 and the support member 340 eachdecouple from the carrier member 310 and the pusher member 320 in themanner described in more detail above with reference to FIGS. 5A-C whenthe tube set 305 is in the first predetermined position. Thereby, thecover member 330 and the support member 340 preferably are inhibitedfrom further axial movement and remain substantially stationary as thecarrier member 310 and the pusher member 320 each remain coupled andaxially slidable.

As shown in FIG. 8H, the cover member 330 and the support member 340remaining substantially stationary while the carrier member 310 and thepusher member 320 continue distally and approach the secondpredetermined position. As the carrier member 310 and the pusher member320 distally advance toward the second predetermined position, theannular cavity 370 moves distally relative to thesubstantially-stationary cover member 330 such that the distal endregion 330 b of the cover member 330 no longer encloses the annularcavity 370.

Thereby, the substantially tubular closure element 500″ is notcompletely enclosed by the annular cavity 370 formed by the distal endregions 310 b, 320 b, and 330 b of the carrier member 310, the pushermember 320, and the cover member 330.

Although not completely enclosed by the annular cavity 370, thesubstantially tubular closure element 500″ is advantageously retained onthe outer periphery 312 b of the carrier member 310 by the distal endregion 330 b of the cover member 330 as illustrated in FIG. 8H. Forexample, by retaining the substantially tubular closure element 500″between the distal end region 330 b of the cover member 330 and thedistal end region 310 b the carrier member 310, the apparatus 100 isconfigured to provide better tissue penetration. The timing between thedeployment of the substantially tubular closure element 500″ by the tubeset 305 and the retraction and transition to the unexpanded state by thelocator assembly 200 likewise is facilitated because the substantiallytubular closure element 500″ is retained between the distal end region330 b and the distal end region 310 b. Further, the carrier member 310and the cover member 330 operate to maintain the substantially tubularclosure element 500″ in the tubular configuration.

When the tube set 305 is in the second predetermined position, thecarrier member 310 decouples from the pusher member 320 in the mannerdescribed in more detail above with reference to FIGS. 5A-C. Therefore,the carrier member 310, the cover member 330, and the support member 340preferably are inhibited from further axial movement and remainsubstantially stationary; whereas, the pusher member 320 remains axiallyslidable. As the pusher member 320 continues distally, the distal endregion 320 b of the pusher member 320 contacts the substantially tubularclosure element 500″ and displaces the substantially tubular closureelement 500″ from the space 360 as shown in FIG. 8I. Since the space 360is substantially radially exposed, the pusher member 320 directs thesubstantially tubular closure element 500″ over the distally-increasingcross-section of the distal end region 310 b of thesubstantially-stationary carrier member 310 such that the cross-section530′ (shown in FIGS. 6F-G) of the substantially tubular closure element500″ begins to radially expand, preferably in a substantially uniformmanner. As the substantially tubular closure element 500″ traverses thedistally-increasing cross-section of the distal end region 310 b, thecross-section 530′ of the substantially tubular closure element 500″radially expands beyond natural cross-section 530 (shown in FIGS. 6A-B)of the closure element 500.

Upon being directed over the distally-increasing cross-section of thedistal end region 310 b by the pusher member 320, the substantiallytubular closure element 500″ is distally deployed as illustrated in FIG.8J. When the substantially tubular closure element 500″ is deployed, thetines 520 can pierce and otherwise engage significant amount of theblood vessel wall 620 and/or tissue 630 adjacent to the opening 610. Forexample, the tines 520 can engage a significant amount of the bloodvessel wall 620 and/or tissue 630 because the cross-section 530′ of thesubstantially tubular closure element 500″ is expanded beyond naturalcross-section 530 of the closure element 500 during deployment.

As the closure element is being deployed from the space 360, the locatorassembly 200 also begins to retract proximally and the locator releasesystem 490 (shown in FIG. 4D) can be activated to transition from theexpanded state to the unexpanded state as the substantially tubularclosure element 500″ is deployed as shown in FIG. 8J. Preferably, thedistal end region 210 b of the locator assembly 200 retracts proximallyand transitions from the expanded state to the unexpanded statesubstantially simultaneously with the deployment of the substantiallytubular closure element 500″. As desired, the distal end region 210 bmay be configured to draw the blood vessel wall 620 and/or tissue 630adjacent to the opening 610 proximally and into the channel 540 definedby the substantially tubular closure element 500″. The tines 520 of thesubstantially tubular closure element 500″ thereby can pierce andotherwise engage the drawn blood vessel wall 620 and/or tissue 630.Since the cross-section 530′ of the substantially tubular closureelement 500″ is expanded beyond natural cross-section 530 of the closureelement 500, a significant amount of the blood vessel wall 620 and/ortissue 630 can be drawn into the channel 540 and engaged by the tines520.

Turning to FIG. 8K, the substantially tubular closure element 500′, oncedeployed, begins to transition from the tubular configuration, returningto the natural, planar configuration with opposing tines 520 and anatural cross-section 530 of the closure element 500. Preferably, thesubstantially tubular closure element 500″ substantially uniformlytransitions from the tubular configuration to the natural, planarconfiguration. Rotating axially inwardly to form the opposing tines 520of the closure element 500, the tines 520 draw the tissue 630 into thechannel 540 as the substantially tubular closure element 500″ forms theclosure element 500. Also, the tissue 630 is drawn substantially closedand/or sealed as the cross-section 530′ of the substantially tubularclosure element 500″ contracts to return to the natural cross-section530 of the closure element 500. Thereby, the opening 610 in the bloodvessel wall 620 can be drawn substantially closed and/or sealed via theclosure element 500 as illustrated in FIG. 8L.

It will be appreciated that the closure element 500 may be constructedof other materials, that it may comprise alternative shapes, and that itmay adopt alternative methods of operation such that the closure element500 achieves closure of openings in blood vessel walls or other bodytissue. In an additional non-limiting example, the closure element 500is constructed of materials that use a magnetic force to couple a pairof securing elements in order to close an opening in the lumen wall ortissue. In this alternative embodiment, the closure element 500 may beof a unitary or multi-component construction having a first securingelement positionable at a first position adjacent the opening, and asecond securing element positionable at a second position adjacent theopening. The first and second securing elements are provided having amagnetic force biasing the first and second securing elements together,thereby closing the opening, or they are provided having a magneticforce biasing both the first and second securing elements toward a thirdsecuring element positioned in a manner to cause closure of the opening.The magnetic closure element 500 may be provided without tines 520,provided the magnetic force coupling the closure elements is sufficientto close the opening. Alternatively, the closure element 500 may beprovided with a combination of the magnetic securing elements and tines520 to provide a combination of coupling forces. Other and furthermaterials, methods, and combinations may be utilized to construct theclosure element 500 to achieve the objectives described and impliedherein.

It will be appreciated that the distal end region 380 b of the housing380 can be configured to couple with an introducer sheath 700 as shownin FIG. 9. Comprising a substantially flexible or semi-rigid tubularmember, the introducer sheath 700 has a proximal end region 700 a and adistal end region 700 b and includes a predetermined length and apredetermined cross-section, both of which can be of any suitabledimension. The distal end region 700 b is configured to facilitateinsertion of the introducer sheath 700 through tissue and/or into theopening 610 (shown in FIG. 8A) formed in and/or adjacent to the wall 620(shown in FIG. 8A) of the blood vessel 600 (shown in FIG. 8A) or otherbody lumen. For example, the distal end region 430 b can have a taperedtip (not shown) for facilitating substantially atraumatic introductionof the introducer sheath 700 through a passage formed in the tissue 630and/or at least partially into the blood vessel wall 620, which isaccessible via the passage. The introducer sheath 700 has an externalcross-section 708 b. The external cross-section 708 b of introducersheath 700 can be of any suitable dimension, and, as desired can besized such that the introducer sheath 700 can be slidably received andadvanced within the lumen 644 (shown in FIG. 8A) of the sheath 640.

The introducer sheath 700 also forms a lumen 704 that extends along alongitudinal axis of the introducer sheath 700 and substantially betweenthe proximal and distal end regions 700 a, 700 b. The lumen 704 can haveany suitable length 708 a and internal cross-section 708 b and isconfigured to slidably receive the tubular body 210 of the locatorassembly 200 (shown in FIG. 4A) and/or the tube set 305 of the carrierassembly 300 (shown in FIG. 4A). Since the internal cross-section 708 bof the introducer sheath 700 typically is less than or substantiallyequal to the predetermined cross-section 338 b of the cover member 330,the introducer sheath 700 may be configured to radially expand, such asby stretching, to receive the tube set 305. Alternatively, or inaddition, the introducer sheath 700 can be advantageously configured tosplit as the tube set 305 is received by, and advances within, the lumen704 of the introducer sheath 700 in the manner described in more detailabove with reference to the sheath 640 (shown in FIG. 8A). To facilitatethe splitting, the introducer sheath 700 can include one or more splits(not shown), such as longitudinal splits, each split being provided inthe manner known in the art. Each split is configured to split theintroducer sheath 700 in accordance with a predetermined pattern, suchas in a spiral pattern. It will be appreciated that, when the internalcross-section 708 b of the introducer sheath 700 is greater than thepredetermined cross-section 338 b of the cover member 330, it may not benecessary for the introducer sheath 700 to be configured to radiallyexpand and/or split.

The introducer sheath 700 can be coupled with the housing 380 via one ormore cooperating connectors (not shown) such that the lumen 704 issubstantially axially aligned with the tubular body 210 of the locatorassembly 200 and/or the tube set 305 of the carrier assembly 300 and, asdesired, may be removably and/or substantially permanently coupled withthe housing 380. For example, a hub assembly 710 can be provided on thedistal end region of the housing 380 b and configured to couple with theproximal end region 700 a of the introducer sheath 700. The proximal endregion 430 a of the introducer sheath 700 is coupled with, or otherwiseprovided on, a distal end region 710 b of the hub assembly 710, such asvia an adhesive, one or more cooperating connectors, and/or athermo-mechanical joint.

The hub assembly 710 also includes a proximal end region 710 a, whichprovides the one or more mating connectors for coupling the introducersheath 700 with the housing 380 and forms a lumen (not shown), whichextends substantially between the proximal end region 710 a and thedistal end region 710 b. The lumen of the hub assembly 710 preferablyhas an internal cross-section or size that is greater than the internalcross-section or size of the lumen 704 of the introducer sheath 700.When the proximal end region 710 a of the lumen 704 is properlyconnected with the hub assembly 710, the lumen of the hub assembly 710is configured to communicate with the lumen 704 of the introducer sheath700. As desired, the proximal end region 700 a of the introducer sheath700 may be flared to facilitate the connection between the introducersheath 700 and the hub assembly 710.

When properly assembled, the hub assembly 710 preferably issubstantially fluid tight such that the one or more devices can beinserted into the lumen 704 of the introducer sheath 700 without fluidpassing proximally through the lumen 704. The hub assembly 710 can bemade to be watertight, such as via one or more seals (not shown) and/orvalves (not shown), and/or other watertight mechanisms. For example, thehub assembly 710 can include a thrust washer and/or valve, a guide fordirecting the devices into the lumen 704 of the introducer sheath 700,and/or a seal (collectively not shown). The various seals and/or guidescan be coupled with the hub assembly 710 via, for example, one or morespacers and/or end caps (also collectively not shown).

As desired, the hub assembly 710 further can include one or more sideports 720. The side ports 720 can communicate with the lumen of the hubassembly 710 and/or the lumen 704 of the introducer sheath 700. At leastone of the side ports 720 can be configured to be connected with, and tocommunicate with, tubing (not shown) to, for example, infuse fluids intothe lumen 704 and through the introducer sheath 700. Alternatively, orin addition, at least one of the side ports 720 can provide a “bleedback” indicator, such as in the manner disclosed in the co-pendingapplication Ser. No. 09/680,837. The disclosures of this reference andany others cited therein are expressly incorporated herein by reference.

An alternative embodiment of the apparatus is shown in FIGS. 10-15. Theembodiment of FIGS. 10-15 has many identical or similar structures thatperform identical or similar functions to the embodiment described aboveand in reference to the preceding Figures. In the description of thealternative embodiment below, and in FIGS. 10-15, components of theapparatus that are identical or substantially correspond to thosepreviously described will bear the same reference numerals identifiedabove with the addition of the prime (′) identifier.

Turning to FIGS. 10 and 11, the locator assembly 200′ is substantiallysimilar to the structure described above in reference to FIGS. 2A-D,including a flexible or semi-rigid tubular body 210′ (such as anelongate rail) with a longitudinal axis. The tubular body 210′ has aproximal end region 210 a′ and a distal end region 210 b′ and includes apredetermined length 218 a′ and a predetermined outer cross-section,both of which can be of any suitable dimension. The distal end region210 b′ of the locator assembly 200′ preferably includes a substantiallyrounded, soft, and/or flexible distal end or tip 220′ to facilitateatraumatic advancement and/or retraction of the distal end region 210 b′into the blood vessel 600. As desired, a pigtail (not shown) may beprovided on the distal end 220′ to further aid atraumatic advancement ofthe distal end region 210 b′.

The distal end region 210 b′ of the locator assembly 200′ further isselectably controllable between an unexpanded state and an expandedstate, in the manner described above in relation to FIGS. 2A-D. In thealternative embodiment shown in FIGS. 10A-B, the distal end region isshown in its expanded state, wherein the substantially flexible members230′ of the expansion elements 230′ are flexed outward.

A control member 250′, such as a rod, wire, or other elongate member,can be moveably disposed within a lumen (not shown) formed by thetubular body 210′ and extending substantially between the proximal endregion 210 a′ and the distal end region 210 b′. The control member 250′has a proximal end region 250 a′ that is coupled with a control block260′, and a distal end region that is coupled with the distal end region210 b′ of the locator assembly 200′, the expansion elements 230′, and/orthe movable end regions 230 c′ of the substantially flexible members230′. The control block 260′ is preferably of a tubular shape and formedof a metal or rigid plastic, and is adapted to be retained in a controlblock cavity 265′ (see FIG. 10B) formed on the internal surface of thehousing bottom half 380 d′, to thereby maintain the control block 260′in a substantially fixed position relative to the housing 380′. Thelocator control system can selectively transition the distal end region210 b′, the expansion elements 230′, and/or the substantially flexiblemembers 230′ between the unexpanded and expanded states by moving thetubular body 210′ axially relative to the control member 250′.

Formed on the proximal end 210 a′ of the tubular body 210′ is a tubularbody block 270′ having a proximal groove 271′. The tubular body block270′ is formed of metal, rigid plastic, or other substantially rigidmaterial and is preferably formed integrally with or attached securelyto the tubular body 210′. The proximal groove 271′ and the proximal endof the tubular body block 270′ have a shape adapted to cooperate with apair of tabs 281 a′-b′ formed on a locator assembly block 280′ wherebythe tubular body block 270′ is maintained in a fixed axial relationshipwith the locator assembly block 280′. In this way, the tubular bodyblock 270′ and tubular body 210′ are advanced distally by distaladvancement of the locator assembly block 280′.

A locator assembly spring 290′ is located coaxially with andsubstantially surrounds a portion of the tubular body block 270′. Thelocator assembly spring 290′ is located between and contacts the distalside of two of the tabs 281 a formed on the locator assembly block 280′,and the proximal side of a locator assembly spring stop 381′ formed onthe inner surface of the housing bottom half 380 d′ (see FIG. 10B). Thelocator assembly spring 290′ so located provides a force biasing thelocator assembly block 280′ in the proximal direction relative to thehousing 380′.

The locator assembly block 280′ is preferably formed of metal, plastic,or other rigid material. A function of the locator assembly block 280′is to allow the user to apply a force causing distal movement of thetubular body 210′ relative to the control member 250′ to cause thelocator assembly 200′ to transition from the unexpanded state to theexpanded state. The proximal end of the locator assembly block 280′ hasa slot 281′ formed therein, the slot 281′ preferably having a sizesufficient to accommodate the control block 260′ and the control blockcavity 265′, and to allow the locator assembly block 280′ to travelaxially relative to the housing 380′. The distal end of the locatorassembly block 280′ has a pair of distally extending forks 282 a-b, witheach of the forks 282 a-b having a ramp 283 a-b on its inward facingsurface. Finally, the locator assembly block 280′ has a pair of distallyextending release tabs 284 a-b, with each of the release tabs 284 a-bhaving a detent 285 a-b.

As shown in FIGS. 11A-B, the locator assembly block 280′ is slidablyreceived and retained within grooves formed in the proximal end of thehousing 380′, with the proximal end of the locator assembly blockextending from the proximal end of the housing. The control block 260′and control block cavity 265 are located in the slot 281′ formed in theproximal end of the locator assembly block 280′.

The locator release system 490′ performs the function of releasing thelocator assembly 200′, thereby allowing the locator assembly 200′ totransition from its expanded state to its unexpanded state. Turning toFIGS. 10A-B and FIG. 15, the locator release system 490′ of thealternative embodiment of the apparatus includes a locator release rod491′ having a release tab spacer block 492′ formed on its proximal end.The locator release rod 491′ and release tab spacer block 492′ arereceived and retained in a groove formed on the interior surface of thehousing bottom half 380 d. The release tab spacer block 492′ ispreferably integrally formed with or attached to the proximal end of thelocator release rod 491′, and is formed of metal, plastic, or otherrigid material. As shown in FIG. 15, the release tab spacer block 492′has a shape and size adapted to fit between the release tabs 284 a-bformed on the locator assembly block 280′, thereby biasing the releasetabs 284 a-b outward and causing the outward facing detents 285 a-b toengage a pair of retaining grooves 286 a-b formed on the interior of thehousing 380′. As long as the detents 285 a-b are thus engaged with theretaining grooves 286 a-b of the housing 380′, the locator assemblyblock 280′ is held in its axial position against the spring forceimparted in the proximal direction by the locator assembly spring 290′.The distal end of the locator release rod 491′ has an engagement member493′ that, in the preferred embodiment, comprises an inward bend on thedistal end of the locator release rod. As described more fully below,the engagement member 493′ on the locator release rod 491′ is preferablypositioned within the apparatus such that, when the closure element 500is delivered, the engagement member 493′ is engaged and caused to moveaxially in the distal direction, thereby disengaging the release tabspacer block 492′ from the locator assembly block 280′ and causing thelocator assembly simultaneously to transition from its expanded state tothe unexpanded state.

The alternative embodiment of the apparatus 100′ includes a carrierassembly 300′ that is coupled with, and slidable relative to, thelocator assembly 200′. The carrier assembly 300′ is configured toreceive and retain the closure element 500 (shown in FIGS. 6A-B), whichpreferably is disposed substantially within the carrier assembly 300′.When the locator assembly 200′ engages the inner surface 620 b (shown inFIG. 8A) of the blood vessel wall 620 (shown in FIG. 8A), the carrierassembly 300′ is further configured to position the closure element 500substantially adjacent to the opening 610 and to deploy the closureelement 500, as described elsewhere herein.

Turning to FIGS. 10A-B, the carrier assembly 300′ includes a tube setcomprising a carrier member 310′, a pusher member 320′, a cover member330′, and a support member 340′. The carrier member 310′, pusher member320′, cover member 330′, and support member 340′ are preferably providedas a plurality of nested, telescoping members with a common longitudinalaxis. The carrier member 310′ is configured to receive and support theclosure element 500. While being disposed on the carrier member 310′,the closure element 500 preferably is deformed from the natural, planarconfiguration to form the substantially tubular closure element 500″(shown in FIGS. 6F-G) as described herein.

The carrier member 310′ includes a proximal end region 310 a′ and adistal end region 310 b′. The carrier member 310′ can also define alumen 314′ that extends substantially between the proximal end region310 a′ and the distal end region 310 b′ and that is configured toslidably receive at least a portion of the tubular body 210′ of thelocator assembly 200′ and/or the support member 340′. Although theexterior cross-section of the carrier member 310′ is substantiallyuniform, the distal end region 310 b′ of the carrier member 310′preferably has a cross-section that increases distally, as illustratedin FIGS. 10A-B, for substantially uniformly expanding the substantiallytubular closure element 500″ beyond the natural cross-section 530 of theclosure element 500 when the substantially tubular closure element 500″is deployed. Alternatively, the distal end region 310 b′ may be formedwith a uniform cross-section to deploy the closure element 500 withoutcross-sectional expansion.

The pusher member 320′ has a proximal end region 320 a′ and a distal endregion 320 b′ and is coupled with, and slidable relative to, the carriermember 310′. The pusher member 320′ includes a predetermined length anda predetermined cross-section, both of which can be of any suitabledimension and can be configured to slidably receive the carrier member310′ such that the distal end region 320 b′ of the pusher member 320′ isoffset proximally from the distal end region 310 b′ of the carriermember 310′. As desired, the predetermined length of the pusher member320′ can be greater than or substantially equal to the predeterminedlength of the carrier member 310′. The predetermined length of thepusher member 320′ preferably is less than the predetermined length ofthe carrier member 310′ such that the carrier member 310′ and the pushermember 320′ at least partially define a space 360′ distal to the distalend region 320 b′ of the pusher member 320′ and along the periphery ofthe carrier member 310′.

The pusher member 320′ preferably is substantially tubular and candefine a lumen 324′ that extends substantially between the proximal endregion 320 a′ and the distal end region 320 b′ and that is configured toslidably receive at least a portion of the carrier member 310′. Thecross-section of the pusher member 320′ preferably is substantiallyuniform, and the distal end region 320 b′ of the pusher member 320′ cancomprise one or more longitudinal extensions 325′, which extend distallyfrom the pusher member 320′ and along the periphery of the carriermember 310′. The longitudinal extensions 325′ preferably are biased suchthat the longitudinal extensions 325′ extend generally in parallel withthe common longitudinal axis of the carrier assembly tube set. Thelongitudinal extensions 325′ are sufficiently flexible to expandradially, and yet sufficiently rigid to inhibit buckling, as the distalend region 320 b′ is directed distally along the carrier member 310′ andengage the distally-increasing cross-section of the distal end region310 b′ of the carrier member 310′ to deploy the substantially tubularclosure element 500″.

The cover member 330′ is configured to retain the substantially tubularclosure element 500″ substantially within the carrier assembly 300′prior to deployment. Being coupled with, and slidable relative to, thepusher member 320′, the cover member 330′ has a proximal end region 330a′ and a distal end region 330 b′ and includes a predetermined lengthand a predetermined cross-section, both of which can be of any suitabledimension. Preferably being formed as a substantially rigid, semi-rigid,or flexible tubular member, the cover member 330′ has an inner peripheryand an outer periphery and can define a lumen 334′. The lumen 334′extends substantially between the proximal and distal end regions 330a′, 330 b′ of the cover member 330′ and can be configured to slidablyreceive at least a portion of the pusher member 320′. When the covermember 330′ is properly positioned within the carrier assembly 300′, thedistal end region 330 b′ is configured to extend over the space 360′,thereby defining an annular cavity 370′ for receiving and retaining thesubstantially tubular closure element 500″.

The cross-section of the cover member 330′ preferably is substantiallyuniform, and the distal end region 330 b′ of the cover member 330′preferably comprises one or more longitudinal extensions 335′, whichextend distally from the cover member 330′ and along an outer peripheryof the pusher member 320′ (see FIG. 3D). Although the longitudinalextensions 335′ can extend generally in parallel with commonlongitudinal axis 350′, the longitudinal extensions 335′ preferably arebiased such that the plurality of longitudinal extensions 335′ extendsubstantially radially inwardly as illustrated in FIGS. 3A and 3D.Thereby, the longitudinal extensions 335′ can at least partially closethe lumen 334′ substantially adjacent to the distal end region 330 b′ ofthe cover member 330′. To permit the substantially tubular closureelement 500″ to be deployed from the annular cavity 370′, thelongitudinal extensions 335′ preferably are sufficiently flexible toexpand radially to permit the distal end region 310 b′ of the carriermember 310′ to move distally past the cover member 330′ to open theannular cavity 370′ such that the distal end region 330 b′ no longerextends over the space 360′.

If the carrier assembly 300′ is assembled as the plurality of nested,telescoping members as shown in FIG. 3A, the carrier member 310′ is atleast partially disposed within, and slidable relative to, the lumen324′ of the pusher member 320′. The support member 340′ is slidablerelative to the pusher member 310′. The pusher member 320′, in turn, isat least partially disposed within, and slidable relative to, the lumen334′ of the cover member 330′. To couple the carrier assembly 300′ withthe locator assembly 200′, the tubular body 210′ of the locator assembly200′ is at least partially disposed within, and slidable relative to,the lumen 314′ of the carrier member 310′. The longitudinal axis of thelocator assembly 200′ preferably is substantially in axial alignmentwith the common longitudinal axis of the carrier member 310′, the pushermember 320′, and the cover member 330′.

The tube set 305 preferably also includes a support member 340′ as shownin FIGS. 10A-B. The support member 340′ is configured to slidablyreceive the tubular body 210′ of the locator assembly 200′ and toprovide radial support for the distal end region 210 b′ of the tubularbody 210′ when the locator assembly 200′ is coupled with the carrierassembly 300′. The carrier assembly 300′ can advantageously include thesupport member 340′, for example, if the tubular body 210′ is notsufficiently rigid or under other circumstances in which support for thetubular body 210′ might be desirable. It also will be appreciated thatthe support member 340′ also can be configured to inhibit the pluralityof longitudinal extensions 335′, which extend from the distal end region330 b′ of the cover member 330′, from expanding prematurely when theclosure element 500 is deployed. If the longitudinal extensions 335′were to expand prematurely, they may become hung up on the introducersheath 640 or other delivery member (in an introducer sheath or deliverymember is used), the tissue 630, or the wall 620 of the blood vessel.This may interfere with the proper advancement or other movement of thecover member 330′ and the carrier assembly 300′.

Preferably being formed as a substantially rigid, semi-rigid, orflexible tubular member, the support member 340′ includes a proximal endregion 340 a′ and a distal end region 340 b′. Having an outer periphery,the support member 340′ can define a lumen 344′ that extendssubstantially between the proximal end region 340 a′ and the distal endregion 340 b′ and that is configured to slidably receive and support atleast a portion of the tubular body 210′ of the locator assembly 200′.The support member 340′, in turn, can be at least partially slidablydisposed within the lumen 314′ of the carrier member 310′ such that thetubular body 210′ of the locator assembly 200′ is coupled with, andslidable relative to, the carrier member 310′ in the manner described inmore detail above. The support member 340′ has a predetermined lengthand a predetermined cross-section, both of which can be of any suitabledimension, and the cross-section preferably is substantially uniform.Although shown and described as being substantially separate forpurposes of illustration, it will be appreciated that the carrier member310′, the pusher member 320′, the cover member 330′, and/or the supportmember 340′ can be provided, in whole or in part, as one or moreintegrated assemblies.

The carrier assembly 300′ also can include a housing 380′, the top half380 c of which is illustrated in FIG. 10A, and the bottom half 380 d ofwhich is shown in FIG. 10B. Preferably being formed as an elongatemember with a longitudinal axis, the housing 380′ has an outer peripheryand includes a proximal end region 380 a′ and a distal end region 380b′. Thereby, when the apparatus 100′ is properly assembled, the tubularbody 210′ of the locator assembly 200′ is at least partially disposedwithin, and slidable relative to, the tube set 305 such that the distalend region 210 b′ of the tubular body 210′ extends beyond the distal endregions 310 b′, 320 b′, 330 b′, and/or 340 b′. The tubular body 210′,the carrier member 310′, the pusher member 320′, the cover member 330′,and, if provided, the support member 340′ are at least partiallydisposed within, and slidable relative to, the housing 380′, and therespective distal end regions 210 b′, 310 b′, 320 b′, 330 b′, and 340 b′extend from the distal end region 380 b′ of the housing 380′ such thatthe common longitudinal axis 350′ of the tube set 305 is substantiallyaxially aligned with the longitudinal axis 386′ of the housing 380′.Being configured to slidably retain the respective proximal end regions210 a′, 310 a′, 320 a′, 330 a′, and 340 a′, the housing 380′ supportsthe tube set 305 and can have one or more handles 391′, 392′ tofacilitate use of the apparatus 100′. The handles 391′, 392′ extendsubstantially radially from the outer periphery of the housing 380′ andcan be provided in the manner known in the art.

When the apparatus 100′ is properly assembled, the tubular body 210′ ofthe locator assembly 200′ is at least partially disposed within, andslidable relative to, the tube set 305 of the carrier assembly 300′ suchthat the distal end region 210 b′ of the tubular body 210′ extendsbeyond the distal end regions 310 b′, 320 b′, 330 b′, and/or 340 b′.Further, the proximal end region 210 a′ of the tubular body 210′ and theproximal end regions 310 a′, 320 a′, 330 a′, and/or 340 a′ of the tubeset 305 are at least partially disposed within, and slidable relativeto, the housing 380′. The switching system of the locator assembly 200′and a switching system of the triggering system 400′ preferably areaccessible external to the housing 380′ as shown in FIGS. 11-15.

As shown in FIGS. 11-15, the triggering system 400′ of the alternativeembodiment of the apparatus 100′ can be disposed substantially withinthe housing 380′. The triggering system 400′ is configured to controlthe relative axial movement and/or positioning of the respective distalend regions 310 b′, 320 b′, 330 b′, and 340 b′ of the tube set 305and/or the distal end region 210 b′ of the locator assembly 200′. Axialmotion of one or more of the carrier member 310′, the pusher member320′, the cover member 330′, and the support member 340′ and/or thetubular body 210′ can be attained, for example, by applying an axialforce to the switching system 405″.

The triggering system 400′ includes a set of block members—a carrierblock 410′, a pusher block 420′, a cover block 430′, and a support block440′—each of which is formed integrally with or securely attached to itsrespective member of the carrier assembly 300′. The block members areadapted to selectably couple and decouple the carrier member 310′, thepusher member 320′, the cover member 330′, and the support member 340′relative to one another in order to provide axial movement of thosecomponents in a predetermined manner intended to deliver the closureelement 500 in the manner described herein. For example, when thecarrier assembly 300′ reaches a first predetermined distal position, thesupport member 340′ can be decoupled from the carrier member 310′, thepusher member 320′, and the cover member 330′ and is thereaftersubstantially inhibited from further axial movement. Thereby, thecarrier member 310′, the pusher member 320′, and the cover member 330′may be directed distally as the support member 340′ remain substantiallystationary. Subsequently, the carrier member 310′ and the cover member330′ can be decoupled from the pusher member 320′ and thereafterinhibited from further axial movement. Thereby, the pusher member 320′may be directed distally as the support member 340′, carrier member310′, and cover member 330′ remain substantially stationary, asdescribed more fully herein.

The carrier block 410′ is disposed on the proximal end region 310 a′ ofthe carrier member 310′ and includes a trigger extension 405′ thatextends through a slot in the housing 380′ to the exterior of thehousing 380′ to be accessible to the user. The carrier block 410′includes a pair of grooves 413 a-b formed on a peripheral surface of thecarrier block 410′, the grooves 413 a-b being adapted to receive andretain a pair of tabs 445 a-b formed on a pair of forks 444 a-bextending distally from the support block 440′, thereby selectablycoupling the support block 440′ to the carrier block 410′. The carrierblock 410′ also includes a pair of distal tabs 416 a-b extending fromthe distal end of the carrier block 410′, and adapted to engage a pairof slots 423 a-b formed on the proximal end of the pusher block 420′.

The carrier block 410′ also includes a pair of forks 414 a-b extendingin the proximal direction from the proximal end of the carrier block,each of the forks having an outward directed tab 415 a-b at its proximalend. The tabs 415 a-b are adapted to selectably engage a pair of slots387 a-b (not shown) formed on the interior surface of the housing 380′near its proximal end and, when so engaged, to fix the axial position ofthe carrier block 410′ and, with it, the carrier assembly 300′ relativeto the housing 380′. The tabs 415 a-b are disengaged from the slots inthe housing when the locator assembly block 280′ is moved axially in thedistal direction in the following manner (see FIG. 11B). As the locatorassembly block 280′ is advanced distally, the interior surfaces of theramps 283 a-b on the locator assembly block forks 282 a-b engage theexterior surfaces of the tabs 415 a-b and cause the carrier block forks414 a-b to flex inward, releasing the tabs 415 a-b from the slots in thehousing, thereby freeing the carrier block 410′ and the carrier assembly300′ to move axially. Thus, axial movement of the carrier block 410′within the apparatus is inhibited until the locator assembly block 280′is advanced to transition the locator assembly 200′ to the expandedcondition, simultaneously releasing the tabs 415 a-b on the carrierblock 410′.

The pusher block 420′ is disposed on the proximal end region 320 a′ ofthe pusher member 320′. As described above, the pusher block 420′includes a pair of slots 423 a-b formed on its proximal end that areadapted to selectably engage the pair of distal tabs 416 a-b extendingfrom the distal end of the carrier block 410′. The pusher block 420′also includes a pair of grooves 424 a-b formed on its peripheralsurface, the grooves 424 a-b being adapted to engage a pair of tabs 435a-b formed on a pair of forks 434 a-b extending from the proximal sideof the cover block 430′ to selectably couple the cover block 430′ to thepusher block 420′.

The cover block 430′ is disposed on the proximal end region 330 a′ ofthe cover member 330′. As described above, the cover block 430′ includesa pair of forks 424 a-b extending from the proximal end of the coverblock 430′, each of the forks having an inward directed tab 435 a-b thatare adapted to engage the grooves 424 a-b on the peripheral surface ofthe pusher block 420′ to selectably couple the cover block 430′ to thepusher block 420′.

The support block 440′ is disposed on the proximal end region 340 a′ ofthe support member 340′. As described above, the support block includesa pair of forks 444 a-b extending from the distal end of the supportblock 440′, each of the forks having an inward directed tab 445 a-b thatare adapted to engage the grooves 413 a-b formed on the surface of thecarrier block 410′ to selectably couple the support block 440′ to thecarrier block 410′.

The carrier block 410′, pusher block 420′, cover block 430′, and supportblock 440′ are shown in FIGS. 11-13 in their fully coupled state, withthe support block 440′ coupled to the carrier block 410′, the pusherblock 420′ coupled to the carrier block 410′, and the cover block 430′coupled to the pusher block 420′. In this arrangement, the carrierassembly 300′ comprises a coaxial set of tubes (as shown, for example,in FIG. 3A), with the support member 340′ slidably retainedsubstantially within the carrier member 310′, which is in turn slidablyretained substantially within the pusher member 320′, which is in turnslidably retained substantially within the cover member 330′.

The triggering system 400′ of the alternative embodiment of theapparatus includes an energy storing element that is used in the finalstage of the closure element 500 delivery process. The energy storingelement, preferably a spring such as the pusher spring 425′ shown inFIGS. 10A-B, is substantially retained in a spring cavity 417′ formed inthe carrier block 410′ and coaxially surrounds a proximal portion 310 a′of the carrier member 310′. The pusher spring 425′ is capable ofexpanding and contracting, storing potential energy as it is contractedand releasing energy as it expands. In its fully expanded state, thepusher spring 425′ has a length that is greater than the length of thespring cavity 417′. The cross-sectional dimension of the pusher spring425′ is such that it backs up against and contacts the proximal end ofthe pusher block 420′. Thus, when the pusher spring 425′ is in placebetween the carrier block 410′ and the pusher block 420′, the pusherspring 425′ is capable of imparting a force biasing the carrier block410′ away from the pusher block 420′.

Prior to delivery of the closure element 500, the distal end of thecarrier block 410′ is in physical contact with the proximal end of thepusher block 420′. In this pre-delivery condition, the pusher spring425′ is in a contracted state and is maintained fully within the springcavity 417′ formed in the carrier block 410′. A catch member 418′ servesthe function of maintaining the carrier block 410′ and pusher block 420′in the pre-delivery condition against the spring force of the pusherspring 425′, the force of which would otherwise force apart the carrierblock 410′ from the pusher block 420′. The catch member 418′ is aU-shaped piece of metal, plastic, or other rigid material that engages afirst groove 418 a formed on the surface of the carrier block 410′ and asecond groove 418 b formed on the surface of the pusher block 420′. Thepusher block 420′ includes a hole 426′ extending through a portionthereof, with one end of the hole 426′ opening into the groove 418 b.The hole 426′ is adapted to receive a trip pin 427′. During the closureelement deployment process, the trip pin 427′ is advanced through thehole 426′, where it encounters the catch member 418′ that is retained inthe groove 418 b. Further advancement of the trip pin 427′ causes thecatch member 418′ to become disengaged from the groove 418 b, therebyreleasing the restraining force on the pusher spring 425′.

The operation of the triggering system 400′ of the alternativeembodiment of the apparatus 100′ is illustrated in FIGS. 11-14 with theclosure element 500 (shown in FIGS. 6A-B) disposed substantially withinthe apparatus 100′. As shown in FIGS. 11A-B, the apparatus has aninitial position in which the locator assembly block 280′ is extendedproximally and the triggering system 400′ is in its most proximalposition. Accordingly, the locator control system 200′ is in itsunexpanded state, as shown. At a point in time that the distal endregion 210 b′ of the locator assembly 200′ has been positioned asdesired (for example, within the blood vessel 600), the locator assemblyblock 280 is depressed distally, as shown in FIG. 12, therebytransitioning the locator assembly to the expanded state and,simultaneously, releasing the triggering system 400′ from the initialposition (in the manner described above) such that the triggering systemcan be advanced distally within the housing 380′.

The triggering system 400′ is then advanced distally within the housing380′, thereby advancing the tube set 305 into position adjacent theblood vessel. At a first predetermined position, shown in FIG. 13, thesupport block 440′ encounters a support stop (not shown) on the interiorsurface of the housing bottom half 380 d that inhibits the support block440′ from advancing further distally. As a result, an application ofadditional distal force to the triggering system 400′ causes the supportblock 440′ to decouple from the carrier block 410′, as shown in FIG. 13.More specifically, the tabs 445 a-b on the forks 444 a-b of the supportblock 440′ disengage from the grooves 413 a-b on the carrier block 410′.Thus, the support block 440′ remains in the position shown in FIG. 13,while the carrier block 410′ is able to advance further distally uponapplication of force to the triggering system 400′.

Turning to FIGS. 14A-B, as the triggering system 400′ is advancedfurther distally, the cover block 430′ engages a cover stop on theinterior surface near the distal end of the housing 380′, therebyinhibiting additional distal advancement of the cover block 430′. Inaddition, the trigger extension 405′ engages the handle 391′ on theexterior of the apparatus, thereby inhibiting additional distaladvancement of the carrier block 410′. At this point, the distal end ofthe tube set corresponds generally to the state illustrated in FIG. 8G,prior to deployment of the closure element 500.

The closure element 500 is next deployed by releasing the pusher spring425′, which causes the pusher block 420′ (and, thus, the pusher member320′) to advance distally, deploying the closure element in the mannerdescribed above. The pusher spring 425′ is released by disengaging thecatch member 418′ from the groove 418 b on the pusher block 420′,thereby releasing the pusher spring 425′ to force the pusher block 420′and, thus, the pusher member 320′—distally relative to the carrier block410′. This action causes the pusher member 320′ to deploy the closureelement 500, as shown, for example, in FIGS. 8H-L. The catch member 418′is disengaged from the groove 418 b by applying a force to the trigger401′, which, in the deployment position, is aligned with the trip pin427′ retained in the pusher block 420′. A trigger spring 402′ biases thetrigger outward relative to the housing 380′. The user applies an inwarddirected force to the trigger 401′ to counteract the biasing force ofthe trigger spring 402′ and force the trigger 401′ against the trip pin427′.

In addition to deploying the closure element 500, the distal advancementof the pusher block 420′ also causes the locator release system 490′ toactivate, thereby transitioning the locator control system 200′ from theexpanded state to the unexpanded state. As the pusher block 420′advances distally to deploy the closure element 500′ in the mannerdescribed above, the pusher block 420′ also engages the engagementmember 493′ of the locator release system 490′ and advances the locatorrelease rod 491′ distally. This action causes the release tab spacerblock 492′ to disengage from the release tabs 284 a-b on the locatorassembly block 280′ (see FIG. 15), thereby releasing the locatorassembly block 280′, which returns to its proximal position, causing thelocator assembly 200′ to return to the unexpanded state. The closureelement 500 deployment and locator release actions occur nearlysimultaneously, as illustrated in FIGS. 8I-K.

As described previously, the apparatus 100 is preferably brought intocontact with the blood vessel 600 by inserting and advancing the distalend of the apparatus through an introducer sheath 640 to the bloodvessel location. Although preferred, the use of an introducer sheath 640is not necessary, as the apparatus can be used to deploy the closureelement 500 without the use of an introducer sheath 640. Furthermore, asdescribe above, when an introducer sheath 640 is used, the locatorassembly 200, 200′ and the carrier assembly 300, 300′ may havecross-sectional dimensions that allow them to be received within theintroducer sheath 640 either without causing radial expansion orsplitting of the sheath, or with causing radial expansion or splittingof the sheath. If the relative cross-sectional dimensions of theintroducer sheath 640 and carrier assembly 300, 300′ are such that theintroducer sheath 640 is intended to be split during advancement of thecarrier assembly 300, 200′, a sheath cutter 701′ having a pointed tip702′ may be utilized to initiate a split at the proximal end of theintroducer sheath 640. The sheath cutter 701′ is advantageously placedcoaxially over the cover member 330′ and is attached to the distal endof the housing 380′ (see FIGS. 11A-B), whereby it will initiate a splitin the introducer sheath 640. Distal advancement of the carrier assembly300, 300′ causes the initial split at the proximal end of the sheath toadvance as the carrier assembly 300, 300′ advances.

Another alternative embodiment of an apparatus for sealing openingsthrough tissue is shown in FIGS. 16-19. The embodiment of FIGS. 16-19,as described below, has many identical or similar structures thatperform identical or similar functions to the embodiments describedabove and in reference to the preceding Figures. Accordingly, thedescription below should be considered in view of the descriptions aboveof the preceding embodiments. Furthermore, those of ordinary skill inthe art will appreciate that one or more of the components and/orfeatures of the embodiment shown in FIGS. 16-19 may also be incorporatedin the previously described embodiments, as those components and/orfeatures of the previously described embodiments may optionally beincorporated in the embodiment described below and in reference to FIGS.16-19.

Turning to FIGS. 16 and 16A, the device 1001 is particularly adapted foruse in conjunction with a guidewire in an over the wire deploymentmethod described below. The device 1001 has a generally elongated bodythat includes, beginning at its proximal end, an actuator cap 1280, agenerally cylindrical actuator housing 1800, a generally cylindricalrelease barrel 1810, a generally cylindrical main housing 1380, and adistal extension 1010. Several components of a locator assembly, acarrier assembly, and a triggering system are contained within the mainhousing 1380, as described more fully below in relation to FIGS. 18 and19. The distal extension 1010 of the device includes an externalprotective sheath 1012 that covers the distal portions of the locatorassembly and carrier assembly. The distal end region 1210 b of thelocator assembly extends out of the distal end of the protective sheath1012.

With particular reference to FIG. 16A, the distal end region 1210 b ofthe locator assembly includes expansion elements 1230 that includesubstantially flexible members 1230′. The substantially flexible members1230′ are able to be selectively controllable between and unexpandedstate (as shown in FIG. 16A) and an expanded state, generally in themanner described above in relation to FIGS. 2A-D. As shown in FIG. 16A,the locator assembly of the alternative embodiment of the device 1001 isprovided with a central lumen 1003, which is preferably of a diametersufficient to accommodate a standard guidewire or other structure, asappropriate. As described below, the central lumen 1003 extends throughthe length of the locator assembly and, thus, through the length of thedevice 1001.

Turning again to FIG. 16, the main housing 1380 includes a pair of grips1392 a-b integrally formed on opposite sides of the main housing 1380.The distal end of the main housing 1380 is gradually tapered 1382, withthe protective sheath 1012 extending out of its distal end. Acylindrical counter spring 1386 is located coaxially on the externalsurface of the main housing 1380 and rests, at its distal end, against ashoulder 1384 formed in the main housing just proximal to the section ofthe main housing upon which the grips 1392 are formed. The proximal endof the counter spring 1386 rests against the release barrel 1810,biasing the release barrel 1810 proximally in relation to the shoulder1384 formed on the main housing 1380. The release barrel 1810 isgenerally cylindrical and coaxially surrounds the main housing 1380. Amechanical linkage 1812 connects the release barrel 1810 to a releaselever 1814 that cooperates with an actuator block 1282, as describedmore fully below in reference to FIGS. 18 and 19. A longitudinal slot1388 is formed on each of the main housing 1380 and the release barrel1810, through which extends a lever 1405 that, as described below, isused to advance the carrier assembly in the distal direction to operatethe device 1001.

A calibration set screw 1818 is located on the release barrel 1810 nearthe distal end of the slot 1388. As the user advances the lever 1405distally to deploy the closure element 500 similar to that describedabove and shown in FIGS. 6 a-6 g, the lever 1405 will eventually engagethe calibration set screw 1818. As described below, further distaladvancement of the lever 1405 causes the actuator block 1282 to release,thereby causing the locator assembly to release the expansion elements1230 and 1230′ from the expanded state to the unexpanded state. Thus,the setting of the calibration set screw 1818 allows the user to finetune the synchronization of the release of the locator assembly with thedeployment of the closure element 500, as described below.

The actuator housing 1800 is attached by a screw 1802 to the proximalend of the main housing 1380, and extends proximally from the mainhousing 1380. A longitudinal slot 1804 is formed in the actuator housing1800 to accommodate the release lever 1814 and the linkage 1812 (seeFIGS. 18-19). The actuator cap 1280 extends out from the proximal end ofthe actuator housing 1800. The actuator cap 1280 is a generallycylindrical body that is coaxial with and generally internal of theactuator housing 1800. The actuator cap 1280 includes a slide seal 1288at its proximal end that is slidable and that provides a fluid-tightseal, as described in more detail below. Additional details concerningthe actuator are described below in reference to FIGS. 18 and 19.

Turning to FIGS. 17 and 17A, the proximal end of the device is shown inmore detail. As shown, the slide seal 1288 on the actuator cap 1280 hasbeen slid to an open position to expose the interior of the actuator.The slide seal 1288 is provided with a pair of tabs 1287 that cooperatewith a pair of slots 1289 formed on the proximal end of the actuator cap1280 to allow the slide seal 1288 to slide in relation to the actuatorcap 1280. The actuator cap 1280 includes a seal 1281, such as an o-ring,that provides a fluid tight seal with the slide seal 1288.

As described above and as shown in FIGS. 17 and 17A, the central lumen1003 extends longitudinally through the center of the device and isaccessible at the proximal end of the actuator cap 1280 when the slideseal 1288 is in the open position. Additional details concerning thecentral lumen 1003 are described below in relation to the additionalFigures.

FIG. 17 provides additional detail concerning the shape and orientationof the grips 1392 formed on the main housing. As shown, the grips 1392extend radially outward on opposite sides of a point near the distal endof the main housing 1380, and provide the user with the ability to gripthe housing with two fingers while operating the lever 1405 with theuser's thumb. Also shown in FIGS. 17 and 17A is the slot 1804 formed inthe actuator housing 1800 to accommodate the release lever 1814.

FIGS. 18, 18A, and 18B show a cross-section of the proximal portion ofthe device 1001, including the previously described main housing 1380,the release barrel 1810 located coaxially in a slidable relation on theexternal surface of the main housing, the counter spring 1386 thatbiases the release barrel proximally relative to the shoulder 1384formed on the main housing, the actuator housing 1800 extendingproximally from the proximal end of the main housing, the linkage 1812and release lever 1814 connected to the release barrel 1810, and theactuator cap 1280 extending proximally from the proximal end of theactuator housing 1800. The actuator cap 1280 is attached to, or formedintegrally with, an actuator block 1282 that is generally cylindricaland that is adapted to slide longitudinally within an actuator base1284. The actuator base 1284, in turn, is attached by the screw 1802 tothe proximal end of the main housing 1380 and the distal end of theactuator housing 1800, as shown in FIG. 18.

The central lumen 1003 is shown extending through the length of thedevice along its longitudinal axis. The central lumen 1003 is defined bythe interior diameter of the tubular body 1210 of the locator assembly1200, which extends from the proximal end region 1210 a to a distal endregion 1210 b (see FIG. 16A). The proximal end region 1210 a of thetubular body 1210 is attached or otherwise connected to the actuatorblock 1282 such that when the actuator block 1282 is advanced distallythe tubular body 1210 is also advanced distally, thereby causing theflexible members 1230′ to buckle and/or expand transversely outwardly,(in the manner described above, for example, in relation to FIGS. 2A-D),thereby transitioning the distal end region 1210 b of the locatorassembly 1200 from the unexpanded state to the expanded state. Forexample, in FIG. 18, the actuator cap 1280 is shown in the extendedposition, consistent with the locator assembly 1200 being in theunexpanded state. In FIG. 19, the actuator cap 1280 is shown in thedepressed position, consistent with the locator assembly 1200 being inthe expanded state. An actuator spring 1286 is located in a chamber 1285formed within the interior of the device between the distal end of theactuator block 1282 and the actuator base 1284 attached to the proximalend of the main housing 1380 and the distal end of the actuator housing1800. The actuator spring 1286 biases the actuator block 1282 in theproximal direction. Depressing the actuator cap 1280 causes the actuatorspring 1286 to compress within the chamber 1285. Once the actuator capis fully depressed, the release lever 1814 is rotated inwardly such thata catch 1816 formed on the release lever engages a slot 1283 formed onthe actuator block 1282, thereby holding the actuator block 1282 inplace in the depressed position against the spring force of the actuatorspring 1286. The release lever 1814 may be disengaged, thustransitioning the locator assembly 1200 from the expanded state to theunexpanded state, either by manually releasing the release lever 1814from the actuator block 1282 and allowing the actuator block to extendproximally, or by advancing the carrier assembly lever 1405 distally toengage the calibration set screw 1818 on the release barrel 1810 andapplying additional distal force to the lever 1405 (and, thus, therelease barrel 1810) to cause the release lever 1814 to disengage fromthe actuator block 1282.

A tube set 1305 is located within the interior of the main housing 1380,extending distally through the distal extension 1010. The tube set 1305shown in FIG. 18 includes a carrier tube 1310, a pusher tube 1320, and acover tube 1330, each located in a coaxial orientation with each otherand with the tubular body 1210 of the locator assembly 1200. The tubeset 1305 has a structure otherwise substantially identical to thatdescribed above in relation to FIGS. 3A-E. The cover tube 1330 isconnected or otherwise attached at its proximal end to a cover block1430. The pusher tube 1320, similarly, is connected or otherwiseattached at its proximal end to a pusher block 1420. Finally, thecarrier tube 1310 is connected or otherwise attached at its proximal endto a carrier block 1410. The lever 1405 is attached to the pusher block1420. Thus, any movement of the lever 1405 will cause the pusher block1420 to move as well.

A leaf spring 1418 connects the carrier block 1410 to the pusher block1420, as shown in FIG. 18B. The leaf spring 1418 is generally flat andextends longitudinally parallel to the central axis of the device. A lip1419 is formed on the distal end of the leaf spring 1418, the lip 1419oriented such that it engages the distal end of the pusher block 1420,effectively locking the pusher block 1420 to the carrier block 1410until the leaf spring 1418 is disengaged from the pusher block 1420, asdescribed below. As long as the pusher block 1420 is thereby locked tothe carrier block 1410, advancement of the lever 1405 will causeadvancement of the combination of the carrier block 1410 and the pusherblock 1420.

A guide pin 1900 is located and fixed on the interior of the mainhousing 1380, and extends proximally from the distal wall of theinterior of the main housing. The guide pin 1900 is received within aslot 1902 formed in the pusher block 1420 and cover block 1430, andprevents the pusher block 1420 and cover block 1430 from rotating insidethe main housing 1380.

A grooved pin 1910 is also located and fixed on the interior of the mainhousing 1380, and extends proximally from the distal wall of theinterior of the main housing 1380. The grooved pin 1910 is preferablylocated on an opposite side of the interior of the main housing from theguide pin 1900. The grooved pin 1910 has a taper 1912 formed on itsproximal end and a transverse groove 1914 formed just distally from thebeginning of the taper 1912. The location and orientation of the groovedpin 1910 are such that the taper 1912 formed on the grooved pin 1910engages and lifts the leaf spring 1418 from its engagement with thepusher block 1420 as the pusher block 1420 and carrier block 1410 areadvanced distally within the device. As the pusher block 1420 andcarrier block 1410 are advanced still further, the lip 1419 formed onthe leaf spring 1418 engages and locks in place in the transverse groove1914 formed on the grooved pin 1910, thereby preventing the carrierblock 1410 (and, thus, the carrier tube 1310) from advancing any furtherdistally. This position of the device also corresponds to the engagementof the lever 1405 with the calibration set screw 1818 (see FIG. 16). Anyadditional distal movement of the lever 1405 will cause the pusher block1420 to move further distally while the carrier block 1410 remainsstationary, thus causing the pusher tube 1320 to deploy the closureelement 1500, in the manner described above in relation to FIGS. 8A-L.This additional distal movement of the lever 1405 also simultaneouslycauses the release barrel 1810 to move distally and to disengage therelease lever 1814 from the actuator block 1282, thereby releasing theactuator block 1282 and causing the locator assembly 1200 to transitionfrom the expanded state to the unexpanded state.

Referring now to FIGS. 20A-L, methods of use of the device 1001 inaccordance with the present invention will be described. As previouslydescribed above and shown in FIGS. 16-19, the device 1001 is configuredto deploy a closure element 500 over a wire, wherein the over the wiredeployment method utilizing the device 1001 described herein may forexample include the following steps, though methods of use associatedwith the apparatus should not be limited to those described herein orshown in the appended drawings.

Referring now to FIG. 20A, there is shown a vessel 620 disposed below apatient's tissue 630 and skin 650, wherein a guidewire 1950 is showndisposed through an opening formed in the vessel and tissue as describedabove. The guidewire 1950 may be introduced into the blood vessel forthe sole purpose of using the device 1001 to deploy the closure element500, or the guidewire may have already been present from a previouslycompleted interventional procedure. If an introducer sheath is in place,it should be removed prior to use of the apparatus 1001, thereby leavingthe guidewire 1950 in place extending into the blood vessel.

As shown in FIG. 20B, the device 1001 is then threaded over theguidewire 1950 by inserting the proximal end of the guidewire 1950 intothe central lumen of the device 1001 at the distal end of the device,the guidewire is disposed through the device and exits at the proximalend of the device. The device 1001 is then advanced along the guidewireuntil the distal end 210 b of the locator assembly is disposed throughthe opening formed in the blood vessel as shown in FIG. 20C, whereby thecorrect position of the device is confirmed by observing a slight flowof blood out of the proximal end of the device, through the open slideseal 1288 on the actuator cap 1280.

Once the correct position of the device is confirmed, the actuator cap1280 is depressed (i.e., the actuator block 1282 is advanced distally)to deploy the flexible members on the distal end 210 b of the locatorassembly, i.e., to transition the locator assembly from the unexpandedstate to the expanded state. In the expanded state, the flexible membersare able to engage the inside of the vessel wall at the location of theopening in the blood vessel as shown in FIG. 20D. The correct positionof the device at this point may be confirmed by gently pulling on thedevice to feel the resistance of the vessel wall against the flexiblemembers in the expanded state as shown in FIG. 20E. After verifying thecorrect position in this manner, the guidewire may be removed from thevessel and from the device by withdrawing the guidewire through theproximal end of the device. Once the guidewire is removed, the slideseal 1288 on the actuator cap 1280 may be closed to prevent further flowof blood through the device.

Referring now to FIGS. 20F and 20G, the device 1001 is in properposition to deploy the closure element 500. The closure element 500″ isdeployed by advancing the lever 1405, which advances the carrier block1410, pusher block 1420, and cover block 1430 until further distaladvancement of the carrier block 1410 and cover block 1430 are preventedby the interaction of the leaf spring 1418 engaging and locking in placein the transverse groove 1914 formed on the grooved pin 1910, therebypreventing the carrier block 1410 (and, thus, the carrier tube 1310)from advancing any further distally. Further distal advancement of thelever 1405 thereafter causes advancement only of the pusher block 1420,which causes deployment of the closure element 500 in the identicalmanner described above, for example, in relation to FIGS. 8H-L. Inaddition, further distal advancement of the lever 1405 causes the lever1405 simultaneously to engage the release barrel 1810, which in turnpulls the release lever 1814 and frees the actuator block 1282 to springback proximally, transitioning the locator assembly 1200 from theexpanded state to the unexpanded state. The closure element deploymentand locator release actions occur nearly simultaneously, as illustrated,for example, in FIGS. 8I-K.

As shown in FIG. 20G, the closure element 500 is shown in a deployedposition, wherein the closure element has been engaged with the vesselwall to effectively close the opening formed therein. As previouslydescribed and shown in FIGS. 20F and 20G, the closure element 500 isexpanded as it is deployed from the device 1001, wherein by increasingthe diameter of the closure element 500, the closure element may engagetissue adjacent the opening in the tissue. It is contemplated that theclosure element may be configured to penetrate the vessel wall to effecta closure, or partially penetrate the vessel wall to effect closure.

The invention is susceptible to various modifications and alternativeforms, and specific examples thereof have been shown by way of examplein the drawings and are herein described in detail. It should beunderstood, however, that the invention is not to be limited to theparticular forms or methods disclosed, but to the contrary, theinvention is to cover all modifications, equivalents, and alternativesfalling within the spirit and scope of the claims.

1. An apparatus for locating a surface of a body lumen, comprising: alocator assembly including a distal end region configured to extend intoan opening of the body lumen and to selectably engage at least a portionof the body lumen adjacent to the opening, said distal end regionincluding at least one surface engaging element configured to engage thesurface of the body lumen; and a measuring device in electricalcommunication with said surface engaging element, said measuring deviceconfigured to determine changes in measurable characteristics of saidsurface engaging element.
 2. The apparatus of claim 1, said locatorassembly further comprising a control member and said control memberbeing in electrical communication with said measuring device and adistal end of said surface engaging element.
 3. The apparatus of claim2, said locator assembly further comprising a tubular body and whereinsaid tubular body is in electrical communication with said measuringdevice and a proximal end of said surface engaging element and saidtubular body being in indirect electrical communication with saidcontrol member.
 4. The apparatus of claim 2, further comprising a covermember, wherein said cover member is in electrical communication withsaid measuring device, said cover member being selectively electricallyisolated from said tubular body.
 5. The apparatus of claim 1, saidlocator assembly further comprising a plurality of engaging membersconfigured to engage the surface of the body lumen.
 6. The apparatus ofclaim 5, a first engaging member being selectively electrically isolatedfrom a second engaging member.
 7. The apparatus of claim 5, said distalend region being selectably controllable between an unexpanded state andan expanded state for engaging the body lumen.
 8. The apparatus of claim7, said plurality of engaging members being configured to expandsubstantially transversely with respect to a longitudinal axis of saidlocator assembly.
 9. The apparatus of claim 6, said first engagingmember being in electrical communication with a third engaging memberthat is selectively electrically isolated from said second engagingmember.
 10. The apparatus of claim 1, said measurable characteristics ofsaid surface engaging element that change are selected from the groupconsisting of an impedance of said surface engaging element, a pressureon said surface engaging element, changes ultrasonic data near saidsurface engaging element, and combinations thereof.
 11. A method forlocating a surface of a body lumen, comprising: inserting a locatorassembly through an opening of the body lumen, said locator assemblycomprising a distal end region including a surface engaging elementconfigured to selectively engage the surface of the body lumen;positioning said locator assembly in close proximity to the opening ofthe body lumen; measuring a measurable characteristic of said surfaceengaging element within the body lumen; and determining whether saidmeasurable characteristic of said surface engaging element indicatesthat said surface engaging element has engaged the surface of the bodylumen.
 12. The method of claim 11, said measurable characteristicincluding an opening electrical characteristic and the method furthercomprising after positioning said locator assembly within the bodylumen, measuring an initial electrical characteristic of said surfaceengaging element.
 13. The method of claim 12, wherein determiningwhether said measurable characteristic of said surface engaging elementindicates that said surface engaging element has engaged the surface ofthe body lumen further comprises comparing said measured initialelectrical characteristic of said surface engaging element with saidmeasured opening electrical characteristic of said surface engagingelement.
 14. The method of claim 11, said locator assembly furthercomprising a control member and said control member being in electricalcommunication with said measuring device and a distal end of saidsurface engaging element.
 15. The method of claim 14, said locatorassembly further comprising a cover member, said cover member being inelectrical communication with said measuring device, and said covermember being selectively electrically isolated from said control member.16. The method of claim 15, wherein determining whether said openingelectrical characteristic of said surface engaging element indicatesthat said surface engaging element has engaged the surface of the bodylumen further comprises determining whether said cover member and saidcontrol member are in electrical communication.
 17. A surface engagingelement comprising: a proximal end portion including at least oneretaining portion; a distal end portion including at least one retainingportion; and at least one engaging member extending toward said proximalend portion and extending toward said distal end portion, said at leastone engaging member configured to engage a surface of a body lumen. 18.The surface engaging element of claim 17, said surface engaging elementbeing formed from a unitary base material.
 19. The surface engagingelement of claim 18, said surface engaging element being formed by alaser cutting process from said unitary base material.
 20. The surfaceengaging element of claim 18, said unitary base material includingnickel-titanium. 21-24. (canceled)